Dietary strategies for patients with type 2 diabetes in the era of multi-approaches; review and results from the Dietary Intervention Randomized Controlled Trial (DIRECT). Effects of a Mediterranean-Style Diet on the Need for Antihyperglycemic Drug Therapy in Patients With Newly Diagnosed Type 2 Diabetes Effectiveness of A Multifactorial Intervention in Increasing Adherence to the Mediterranean Diet among Patients with Diabetes Mellitus Type 2: A Controlled and Randomized Study (EMID Study) Can the Mediterranean diet lower HbA1c in type 2 diabetes? Results from a randomized cross-over study. Comparative effect of two Mediterranean diets versus a low-fat diet on glycaemic control in individuals with type 2 diabetes Effect of a Lifestyle Intervention Program With Energy-Restricted Mediterranean Diet and Exercise on Weight Loss and Cardiovascular Risk Factors: One-Year Results of the PREDIMED-Plus Trial Reduction in the Incidence of Type 2 Diabetes With the Mediterranean Diet A low carbohydrate Mediterranean diet improves cardiovascular risk factors and diabetes control among overweight patients with type 2 diabetes mellitus: a 1-year prospective randomized intervention study. Impact of a Mediterranean Dietary Pattern and Its Components on Cardiovascular Risk Factors, Glucose Control, and Body Weight in People with Type 2 Diabetes: A Real-Life Study Prevention of Diabetes With Mediterranean Diets Exercise in a behavioural weight control programme for obese patients with Type 2 (non-insulin-dependent) diabetes Long-Term Effect of Mediterranean-Style Diet and Calorie Restriction on Biomarkers of Longevity and Oxidative Stress in Overweight Men The Effects of a Mediterranean Diet on the Need for Diabetes Drugs and Remission of Newly Diagnosed Type 2 Diabetes: Follow-up of a Randomized Trial A randomised controlled trial investigating the effect of an intensive lifestyle intervention v. standard care in adults with type 2 diabetes immediately after initiating insulin therapy. Reduction in risk factors for type 2 diabetes mellitus in response to a low-sugar, high-fiber dietary intervention in overweight Latino adolescents. Mediterranean diet and glycaemic load in relation to incidence of type 2 diabetes: results from the Greek cohort of the population-based European Prospective Investigation into Cancer and Nutrition (EPIC) A low-glycemic load diet facilitates greater weight loss in overweight adults with high insulin secretion but not in overweight adults with low insulin secretion in the CALERIE Trial.
Dietary intervention is recognized as a key component in prevention and management of type 2 diabetes ( T2DM ) and the debate persists : which dietary strategy is most effective . In the Dietary Intervention R and omized Controlled Trial ( DIRECT ) 322 moderately obese participants were r and omized for 2 years to one of three diet groups : low-fat , Mediterranean and low-carbohydrate . Differential effects were observed in the sub-group of patients with T2DM at 24 months : participants r and omized to the Mediterranean diet , which had the highest intake of dietary fibers and unsaturated to saturated fat ratio , achieved greater significant improvements in fasting plasma glucose and insulin levels . Patients who were r and omized to the low-carbohydrate diet , which had the minimal intake of carbohydrates , achieved a significant reduction of hemoglobin A1C . Although improvements were observed in all groups , the low-fat diet was likely to be less beneficial in terms of glycemic control and lipid metabolism . Interpretation of results from different studies on dietary strategies may be complex since there is often no consistency in diet compositions , calorie restriction , intensity of intervention , dietary assessment or extent of adherence in the trial . Nevertheless , it seems that low fat restricted calorie diets are effective for weight loss and are associated with some metabolic benefits ; however , some recent trials have shown that low carbohydrate diets are as efficient in inducing weight loss and in some metabolic measures such as serum triglycerides and HDL-cholesterol may be even superior to low fat diets . When addressing the issue of diet quality rather than quantity applying the glycemic index may have some added benefits . Furthermore special features of the Mediterranean diet have apparent additional favorable effects for patients with T2DM Context Mediterranean-style diets improve control of coronary risk factors and hyperglycemia , but few direct comparisons of the diet with other st and ard diets have been done . Contribution In this r and omized clinical trial , patients with newly diagnosed type 2 diabetes who were assigned to a low-carbohydrate , Mediterranean-style diet had better glycemic control and were less likely to need oral antihyperglycemic therapy than patients assigned to a low-fat diet . Caution The trial was unblinded , and dietary intake was self-reported . Implication A low-carbohydrate , Mediterranean-style diet seems to be preferable to a low-fat diet for glycemic control in patients with newly diagnosed type 2 diabetes . The Editors The p and emic of type 2 diabetes is an enormous public health problem , with 380 million cases worldwide projected by 2025 ( 1 , 2 ) . Lifestyle intervention studies ( 3 ) have demonstrated large reductions in risk for type 2 diabetes that remain after lifestyle counseling is stopped ( 4 , 5 ) . Despite this beneficial effect , the American Diabetes Association ( ADA ) recommends that patients with newly diagnosed type 2 diabetes be treated with pharmacotherapy as well as lifestyle changes ( 6 ) . The rationale for combination therapy is presumably that each form of treatment alone is imperfect . Lifestyle changes are often inadequate because patients do not lose weight or regain weight or their diabetes worsens independent of weight ( 6 ) . Pharmacotherapy also often fails with time ( 7 ) , and some drugs have associated cardiovascular and other risks ( 8 , 9 ) . For those reasons , lifestyle changes proven to be more effective than what is typically recommended would be welcome . For example , Mediterranean-style ( MED ) diets with a high proportion of monounsaturated fat provide cardiovascular benefits and increase insulin sensitivity ( 1012 ) , and the ADA recommends low-carbohydrate or low-fat , calorie-restricted diets for weight loss in overweight and obese patients with type 2 diabetes ( 13 ) . However , few direct , long-term comparisons of the 2 diets in patients with diabetes have been done ( 11 ) . We conducted a r and omized trial to compare the effectiveness , durability , and safety of a low-carbohydrate MED diet and a low-fat diet on glycemic control in patients with newly diagnosed type 2 diabetes . Methods We conducted the trial between January 2004 ( first patient enrolled ) and September 2008 ( end of follow-up of the last patient ) at the research center of the Diabetes Clinic of the Azienda Ospedaliera Universitaria , Second University of Naples , Naples , Italy , in accordance with the Declaration of Helsinki and with the institutional review board 's approval . Screening Phase We recruited men and women with newly diagnosed type 2 diabetes by ADA criteria who had never been treated with antihyperglycemic drugs from the clinical practice s of trial investigators and screened them for eligibility . Inclusion criteria were age 30 to 75 years , body mass index ( BMI ) greater than 25 kg/m2 , and hemoglobin A1c ( HbA1c ) level less than 11 % . Participants also had to be sedentary ( < 1 hour of physical activity per week ) with no evidence of participation in weight-reduction programs and with a stable weight ( 2 kg ) in the past 6 months . Exclusion criteria included pregnancy or breastfeeding , use of any investigational drug in the previous 3 months , use of agents affecting glycemic control ( such as systemic glucocorticoids and weight loss drugs ) , and any condition that might compromise adherence to diet regimens . To minimize the likelihood of including participants with late-onset type 1 diabetes , we screened c and i date s by testing for antibodies to glutamate decarboxylase and measuring fasting plasma C-peptides . We excluded patients with positive antibodies or C-peptide levels less than 0.25 pmol/L ( < 0.76 ng/L ) . We also excluded patients with abnormal laboratory test results , including liver enzyme levels ( alanine aminotransferase , aspartate aminotransferase , and alkaline phosphatase ) greater than 3 times the upper limit of normal and serum creatinine levels greater than 123.8 mol/L ( > 1.4 mg/dL ) . We required that participants successfully self-monitor their diet and physical activity over a 2-week run-in period . We provided dietary education during that time that emphasized the importance of eating a healthy diet and being physically active for both weight loss and improvement of glycemic control . Participants were also taught to prepare their own meals at home . We encouraged all individuals who smoked to quit and provided self-help material s , referral to local programs , or both , as appropriate . R and omization and Blinding After obtaining informed consent , we r and omly assigned patients to 1 of the 2 study diets by using a computer-generated r and om-number sequence ( simple r and omization ) . Allocation was concealed in sealed study folders that were held in a central , secured location until after informed consent was obtained . The nurses who scheduled the study visits did not have access to the r and omization list , and laboratory staff did not know the participants ' group assignments . Staff members involved in the intervention were aware of group assignments , but those who assessed achievement of the primary outcome were blinded to the intervention . Participants received no financial compensation or gifts . Dietary Interventions We r and omly assigned patients to a low-carbohydrate MED diet or to a low-fat diet . The MED diet was rich in vegetables and whole grains and low in red meat , which was replaced with poultry and fish . We restricted energy intake to 1500 kcal/d for women and 1800 kcal/d for men , with the goal of no more than 50 % of calories from complex carbohydrates , based on evidence that , in the context of a MED diet , a carbohydrate content less than 50 % of daily energy is more beneficial than higher content for weight loss and cardiovascular risk reduction ( 14 ) . The diet had no less than 30 % calories from fat . The main source of added fat was 30 to 50 g of olive oil . The low-fat diet was based on American Heart Association guidelines ( 15 ) ; it was rich in whole grains and restricted additional fats , sweets , and high-fat snacks . We restricted energy intake to 1500 kcal/d for women and 1800 kcal/d for men , with the goal of no more than 30 % of calories from fat and no more than 10 % of calories from saturated fat . Nutritionists and dietitians gave dietary advice to participants in both groups in monthly sessions in the first year and bimonthly sessions thereafter . Participants kept diet diaries after being instructed how to record their intake using food models as examples of portion size and using actual weights or amounts in terms of common measures ( such as cups , teaspoons , and dessert spoons ) . We assessed adherence to the diets by session attendance and review of the diaries . Nondietary Interventions Patients in both groups also received guidance on increasing their level of physical activity , mainly walking for a minimum of 30 minutes per day , but also swimming or aerobic ball games . The physical activity program relied heavily on home-based exercise with gradual progression toward a goal of 175 minutes of moderate-intensity physical activity per week . Although walking was encouraged , participants were allowed to choose other types of moderate-intensity physical activity , and programs were tailored on the basis of the results of a baseline physical fitness test and safety concerns . We asked all patients to record occupational , household , and leisure time physical activity . Outcomes We followed patients for 4 years to assess trial outcomes . The primary outcome measure was time to introduction of antihyperglycemic drug therapy . Trial investigators were responsible for initiating drug therapy by the following protocol . As suggested by the ADA for clinical evaluation and management of diabetic patients ( 16 ) , we measured HbA1c at baseline and every 3 months thereafter . Participants who had a HbA1c level greater than 7 % were given an additional 3 months to reinforce dietary guidance and physical activity ; if the HbA1c level remained greater than 7 % , a drug regimen was introduced . Participants with an HbA1c level greater than 7 % at baseline were counted as having experienced the primary outcome if they still had that level at first follow-up . Trial investigators were also responsible for initiating or titrating antihypertensive or lipid-lowering therapy . Secondary outcome measures were changes in weight ( including BMI and waist circumference ) , glycemic control ( HbA1c , glucose , serum insulin , and adiponectin levels and homeostasis model assessment of insulin sensitivity ) , coronary risk factors ( lipid levels and blood pressure ) , and medications and meeting ADA coronary risk factor goals ( HbA1c level < 7 % , blood pressure < 130/80 mm Hg , and low-density lipoprotein cholesterol level < 2.59 mmol/L [ < 100 mg/dL ] ) ( 16 ) . Participants were weighed without shoes and in lightweight clothing to the nearest 0.1 kg at baseline and every month . Height at baseline ( for calculation of BMI ) was measured to the nearest millimeter with the use of a wall-mounted stadiometer ( Seca , Hamburg , Germany ) . Waist circumference was measured halfway between the last rib and the iliac crest . We measured HbA1c levels with high-pressure liquid chromatography by using the fully automated Glycosylated Hemoglobin Analyzer System ( Bio-Rad , Hercules , California ) traceable to the Diabetes Control and Complications Trial reference method , with a reference range of 4.0 % to 6.0 % . Insulin sensitivity in the fasting state was assessed with homeostasis model assessment and calculated with the following formula , as described by Matthews and colleagues ( 17 ) : fasting plasma glucose (mmol/L)fasting serum insulin (U/mL)/25 . High scores indicate low insulin sensitivity ( insulin resistance ) . We assayed plasma insulin and adiponectin levels by radioimmunoassay , as described elsewhere ( 18 ) . We performed assays for serum The Mediterranean diet ( MD ) is recognized as one of the healthiest dietary patterns and has benefits such as improving glycaemic control among patients with type 2 diabetes ( T2DM ) . Our aim is to assess the effectiveness of a multifactorial intervention to improve adherence to the MD , diet quality and biomedical parameters . The EMID study is a r and omized and controlled clinical trial with two parallel groups and a 12-month follow-up period . The study included 204 subjects between 25–70 years with T2DM . The participants were r and omized into intervention group ( IG ) and control group ( CG ) . Both groups received brief advice about healthy eating and physical activity . The IG participants additionally took part in a food workshop , five walks and received a smartphone application for three months . The population studied had a mean age of 60.6 years . At the 3-month follow-up visit , there were improvements in adherence to the MD and diet quality of 2.2 and 2.5 points , compared to the baseline visit , respectively , in favour of the IG . This tendency of the improvement was maintained , in favour of the IG , at the 12-month follow-up visit . In conclusion , the multifactorial intervention performed could improve adherence to the MD and diet quality among patients with T2DM BACKGROUND AND AIMS To investigate the impact of a diet modeled on the traditional Cretan Mediterranean diet on metabolic control and vascular risk in type 2 diabetes . METHODS AND RESULTS Twenty-seven subjects ( 47 - 77 yrs ) with type 2 diabetes were r and omly assigned to consume either the intervention diet ad libitum or their usual diet for 12 weeks and then cross over to the alternate diet . Most of the meals and staple foods for the intervention diet were provided . Lipids , glycemic variables , blood pressure , homocysteine , C-reactive protein , plasma carotenoids and body composition ( anthropometry and dual energy X-ray absorptiometry ) were assessed at baseline , and at the end of both diet periods . Dietary adherence was monitored using plasma carotenoid and fatty acid ( FA ) analysis , complemented by diet diaries . Compared with usual diet , on the ad libitum Mediterranean intervention diet glycosylated haemoglobin fell from 7.1 % ( 95 % CI : 6.5 - 7.7 ) to 6.8 % ( 95 % CI : 6.3 - 7.3 ) ( p=0.012 ) and diet quality improved significantly [ plant : animal ( g/day ) food ratio increased from 1.3 ( 95 % CI : 1.1 - 1.5 ) to 5.4 ( 95 % CI : 4.3 - 6.6 ) ( p<0.001 ) ] , plasma lycopene and lutein/zeaxanthin increased ( 36 % and 25 % , respectively ) , plasma saturated and trans FAs decreased , and monounsaturated FAs increased . CONCLUSION A traditional moderate-fat Mediterranean diet improves glycemic control and diet quality in men and women with well-controlled type 2 diabetes , without adverse effects on weight Background / Objectives : Although benefits have been attributed to the Mediterranean diet , its effect on glycaemic control has not been totally eluci date d. The aim of this work was to compare the effect of two Mediterranean diets versus a low-fat diet on several parameters and indices related to glycaemic control in type 2 diabetic subjects . Subjects/ Methods : A multicentric parallel trial was conducted on 191 participants ( 77 men and 114 women ) of the PREDIMED study in order to compare three dietary interventions : two Mediterranean diets supplemented with virgin olive oil ( n=67 ; body mass index ( BMI ) = 29.4±2.9 ) or mixed nuts ( n=74 ; BMI = 30.1±3.1 ) and a low-fat diet ( n=50 ; BMI = 29.8±2.8 ) . There were no drop-outs . Changes in body weight and waist circumference were determined . Insulin resistance was measured by HOMA-IR index , adiponectin/leptin and adiponectin/HOMA-R ratios after 1 year of follow-up . Results : Increased values of adiponectin/leptin ratio ( P=0.043 , P=0.001 and P<0.001 for low-fat , olive oil and nut diets , respectively ) and adiponectin/HOMA-IR ratio ( P=0.061 , P=0.027 and P=0.069 for low-fat , olive oil and nut diets , respectively ) and decreased values of waist circumference ( P=0.003 , P=0.001 and P=0.001 for low-fat , olive oil and nut diets , respectively ) were observed in the three groups . In both Mediterranean  diet groups , but not in the low-fat diet group , this was associated with a significant reduction in body weight ( P=0.347 , P=0.003 and P=0.021 for low-fat , olive oil and nut diets , respectively ) . Conclusions : Mediterranean diets supplemented with virgin olive oil or nuts  reduced total body weight and improved glucose metabolism to the same extent as the usually recommended low-fat diet OBJECTIVE The long-term impact of intentional weight loss on cardiovascular events remains unknown . We describe 12-month changes in body weight and cardiovascular risk factors in PREvención con DIeta MEDiterránea (PREDIMED)-Plus , a trial design ed to evaluate the long-term effectiveness of an intensive weight loss lifestyle intervention on primary cardiovascular prevention . RESEARCH DESIGN AND METHODS Overweight/obese adults with metabolic syndrome aged 55–75 years ( n = 626 ) were r and omized to an intensive weight loss lifestyle intervention based on an energy-restricted Mediterranean diet , physical activity promotion , and behavioral support ( IG ) or a control group ( CG ) . The primary and secondary outcomes were changes in weight and cardiovascular risk markers , respectively . RESULTS Diet and physical activity changes were in the expected direction , with significant improvements in IG versus CG . After 12 months , IG participants lost an average of 3.2 kg vs. 0.7 kg in the CG ( P < 0.001 ) , a mean difference of −2.5 kg ( 95 % CI −3.1 to −1.9 ) . Weight loss ≥5 % occurred in 33.7 % of IG participants compared with 11.9 % in the CG ( P < 0.001 ) . Compared with the CG , cardiovascular risk factors , including waist circumference , fasting glucose , triglycerides , and HDL cholesterol , significantly improved in IG participants ( P < 0.002 ) . Reductions in insulin resistance , HbA1c , and circulating levels of leptin , interleukin-18 , and MCP-1 were greater in IG than CG participants ( P < 0.05 ) . IG participants with prediabetes/diabetes significantly improved glycemic control and insulin sensitivity , along with triglycerides and HDL cholesterol levels compared with their CG counterparts . CONCLUSIONS PREDIMED-Plus intensive lifestyle intervention for 12 months was effective in decreasing adiposity and improving cardiovascular risk factors in overweight/obese older adults with metabolic syndrome , as well as in individuals with or at risk for diabetes OBJECTIVE To test the effects of two Mediterranean diet ( MedDiet ) interventions versus a low-fat diet on incidence of diabetes . RESEARCH DESIGN AND METHODS This was a three-arm r and omized trial in 418 nondiabetic subjects aged 55–80 years recruited in one center ( PREDIMED-Reus , northeastern Spain ) of the Prevención con Dieta Mediterránea [ PREDIMED ] study , a large nutrition intervention trial for primary cardiovascular prevention in individuals at high cardiovascular risk . Participants were r and omly assigned to education on a low-fat diet ( control group ) or to one of two MedDiets , supplemented with either free virgin olive oil ( 1 liter/week ) or nuts ( 30 g/day ) . Diets were ad libitum , and no advice on physical activity was given . The main outcome was diabetes incidence diagnosed by the 2009 American Diabetes Association criteria . RESULTS After a median follow-up of 4.0 years , diabetes incidence was 10.1 % ( 95 % CI 5.1–15.1 ) , 11.0 % ( 5.9–16.1 ) , and 17.9 % ( 11.4–24.4 ) in the MedDiet with olive oil group , the MedDiet with nuts group , and the control group , respectively . Multivariable adjusted hazard ratios of diabetes were 0.49 ( 0.25–0.97 ) and 0.48 ( 0.24–0.96 ) in the MedDiet supplemented with olive oil and nuts groups , respectively , compared with the control group . When the two MedDiet groups were pooled and compared with the control group , diabetes incidence was reduced by 52 % ( 27–86 ) . In all study arms , increased adherence to the MedDiet was inversely associated with diabetes incidence . Diabetes risk reduction occurred in the absence of significant changes in body weight or physical activity . CONCLUSIONS MedDiets without calorie restriction seem to be effective in the prevention of diabetes in subjects at high cardiovascular risk BACKGROUND The appropriate dietary intervention for overweight persons with type 2 diabetes mellitus ( DM2 ) is unclear . Trials comparing the effectiveness of diets are frequently limited by short follow-up times and high dropout rates . AIM The effects of a low carbohydrate Mediterranean ( LCM ) , a traditional Mediterranean ( TM ) , and the 2003 American Diabetic Association ( ADA ) diet were compared , on health parameters during a 12-month period . METHODS In this 12-month trial , 259 overweight diabetic patients ( mean age 55 years , mean body mass index 31.4 kg/m(2 ) ) were r and omly assigned to one of the three diets . The primary end-points were reduction of fasting plasma glucose , HbA1c and triglyceride ( TG ) levels . RESULTS 194 patients out of 259 ( 74.9 % ) completed follow-up . After 12 months , the mean weight loss for all patients was 8.3 kg : 7.7 kg for ADA , 7.4 kg for TM and 10.1 kg for LCM diets . The reduction in HbA1c was significantly greater in the LCM diet than in the ADA diet ( -2.0 and -1.6 % , respectively , p < 0.022 ) . HDL cholesterol increased ( 0.1 mmol/l + /- 0.02 ) only on the LCM ( p < 0.002 ) . The reduction in serum TG was greater in the LCM ( -1.3 mmol/l ) and TM ( -1.5 mmol/l ) than in the ADA ( -0.7 mmol/l ) , p = 0.001 . CONCLUSIONS An intensive 12-month dietary intervention in a community-based setting was effective in improving most modifiable cardiovascular risk factors in all the dietary groups . Only the LCM improved HDL levels and was superior to both the ADA and TM in improving glycaemic control This study evaluates the relation of a Mediterranean dietary pattern and its individual components with the cardiovascular risk factors profile , plasma glucose and body mass index ( BMI ) in people with type 2 diabetes . We studied 2568 participants at 57 diabetes clinics . Diet was assessed with the EPIC ( European Prospect i ve Investigation into Cancer and Nutrition ) question naire , adherence to the Mediterranean diet was evaluated with the  relative Mediterranean diet score ( rMED ) . A high compared to a low score was associated with a better quality of diet and a greater adherence to the nutritional recommendations for diabetes . However , even in the group achieving a high score , only a small proportion of participants met the recommendations for fiber and saturated fat ( respectively 17 % and 30 % ) . Nonetheless , a high score was associated with lower values of plasma lipids , blood pressure , glycated hemoglobin , and BMI . The relationship of the single food items components of the rMED score with the achievement of treatment targets for plasma lipids , blood pressure , glucose , and BMI were also explored . The study findings support the Mediterranean dietary model as a suitable model for type 2 diabetes and the concept that the beneficial health effects of the Mediterranean diet lie primarily in its synergy among various nutrients and foods rather than on any individual component Context Can changes in diet prevent diabetes in older adults ? Contribution This subgroup analysis of a multicenter trial involved older adults with high risk for heart disease who were r and omly assigned to a Mediterranean diet supplemented with either extra-virgin olive oil or mixed nuts or to a low-fat control diet . Neither energy restriction nor increased physical activity was advised . After 4 years of follow-up , fewer persons in the Mediterranean diet groups developed diabetes than in the control group . Implication Changes in dietary patterns that do not necessarily lead to weight loss or include energy restrictions could help prevent diabetes in some older adults . The Editors Type 2 diabetes mellitus represents a major health problem because worldwide prevalence has more than doubled in the past 3 decades , with nearly 347 million persons with diabetes in 2010 ( 1 ) , and is a potent risk factor for cardiovascular disease ( CVD ) , blindness , renal failure , and lower limb amputation ( 2 ) . Compelling evidence shows that diabetes can be prevented with lifestyle changes . Intensive lifestyle modification promoting weight loss through energy-restricted diets together with increased physical activity can decrease incident diabetes to as low as 50 % ( 3 ) . Indeed , lifestyle modification has performed better than pharmacologic approaches ( such as metformin or rosiglitazone ) in diabetes prevention ( 46 ) . Of interest , the benefit of lifestyle changes in decreasing diabetes risk seems to extend beyond the termination of active intervention ( 68 ) . However , there is little information on whether changes in the overall dietary pattern , without energy restriction , increased physical activity , and ensuing weight loss , may also be effective to prevent diabetes . Prospect i ve epidemiologic studies strongly suggest that dietary patterns characterized by high consumption of fruit , vegetables , whole grains , and fish and reduced consumption of red and processed meat , sugar-sweetened beverages , and starchy foods delay diabetes onset ( 9 ) . In the last 6 years , the traditional Mediterranean diet has emerged as a healthy dietary pattern that is also associated with a decreased risk for diabetes ( 1012 ) . The Mediterranean diet is moderately rich in fat ( 35 % to 40 % of energy ) , especially from vegetable sources ( rich in olive oil and nuts ) , and relatively low in dairy products . Moderate consumption of alcohol , mostly wine , and frequent use of sauces with tomato , onions , garlic , and spices for meal preparation are also typical . Preliminary data from the PREDIMED ( Prevencin con Dieta Mediterrnea ) study ( 1317 ) showed that traditional Mediterranean diets enriched with high-fat foods of vegetable origin decreased the incidence of diabetes ( 18 ) . However , that report studied participants only from 1 of the 11 PREDIMED recruiting centers . In this analysis , we provide the final results on diabetes incidence in the whole multicenter trial after a median follow-up of 4.1 years . Methods Design Overview The PREDIMED study is a parallel-group , r and omized , primary cardiovascular prevention trial done in Spain in persons at high risk but without CVD at baseline . The protocol , design , objectives , and methods have been reported in detail elsewhere ( 13 , 14 ) . Briefly , participants were r and omly assigned in a 1:1:1 ratio to 1 of 3 nutrition interventions : Mediterranean diet supplemented with extra-virgin olive oil ( EVOO ) , Mediterranean diet supplemented with mixed nuts , or a control diet consisting of advice to reduce intake of all types of fat . A complete list of PREDIMED study investigators is available in Supplement 1 . The local institutional review boards approved the protocol at each study location , and all participants provided written informed consent . Supplement . Original Version ( PDF ) Supplement 1 . List of Prevencin con Dieta Mediterrnea Study Investigators Setting and Participants Eligible participants were community-dwelling men ( aged 55 to 80 years ) and women ( aged 60 to 80 years ) without CVD at baseline who had either type 2 diabetes or at least 3 or more cardiovascular risk factors , namely current smoking , hypertension , hypercholesterolemia , low high-density lipoprotein cholesterol levels , overweight or obesity , and family history of premature CVD . Exclusion criteria have previously been reported ( 13 ) . R and omization and Intervention From October 2003 to June 2009 , 7447 suitable c and i date s were enrolled in the trial . The study nurse from each recruiting center r and omly assigned each participant to the corresponding intervention group following computer-generated r and om numbers for allocation contained in sealed envelopes , which were central ly prepared for each center by the coordinating unit . Four strata of r and omization were built by sex and age ( cutoff , 70 years ) but not by baseline diabetes status . The primary care physicians did not participate in the r and omization process . The study nurses were independent of the nursing staff of the primary care health centers . Therefore , they were not involved in the usual clinical care of participants , and their exclusive role was to collect data for the trial . Given the nature of the interventions ( nutritional advice and provision of foods ) , only investigators assessing outcomes were blinded with respect to intervention assignment . This was done by providing them with coded data sets and medical records blinded with respect to the personal identity of the participant and without any information on treatment allocation . Because our main objective was to determine the effect of the 3 interventions on diabetes incidence , this report includes data only on participants who did not have diabetes at baseline and for whom we could ascertain the incidence of diabetes during follow-up ( n= 3541 ) ( Figure 1 ) . Figure 1 . Study flow diagram . EVOO = extra-virgin olive oil ; MedDiet = Mediterranean diet . A behavioral intervention promoting the Mediterranean diet was implemented in the corresponding groups of the trial , as described ( 13 ) . Dietitians gave personalized advice to participants about the amount and use of EVOO for cooking and dressing ; weekly intake of nuts ; increased consumption of vegetables , fruits , legumes , and fish ; recommended intake of white meat instead of red or processed meat ; avoidance of butter , fast food , sweets , pastries , or sugar-sweetened beverages ; and the dressing of dishes with sofrito sauce ( using tomato , garlic , onion , and spices simmered in olive oil ) . Reduction of alcoholic beverages other than wine was advised to all participants . Wine with meals was recommended with moderation only to habitual drinkers . At baseline and quarterly thereafter , dietitians conducted individual and group dietary training sessions to provide information on typical Mediterranean foods , seasonal shopping lists , meal plans , and recipes for each group . In each session , a 14-item question naire was used to assess adherence to the Mediterranean diet ( 13 , 14 ) so that personalized advice could be provided to up grade participants adherence . The same question naire was assessed yearly in the control group . Participants assigned to the 2 Mediterranean diet groups received allotments of either EVOO ( 50 mL/d ) or mixed nuts ( 30 g/d : 15 g of walnuts , 7.5 g of almonds , and 7.5 g of hazelnuts ) at no cost . Participants assigned to the control diet received recommendations to reduce intake of all types of fat ( from both animal and vegetable sources ) and received nonfood gifts ( kitchenware , tableware , aprons , or shopping bags ) . Through October 2006 , participants in the control group received only a leaflet describing the low-fat diet . Thereafter , participants assigned to the control diet also received personalized advice and were invited to group sessions with the same frequency and intensity as those in the Mediterranean diet groups . A separate 9-item dietary question naire ( 14 ) was used to assess adherence to the low-fat diet . Neither energy restriction nor increased physical activity was advised for any intervention group . At baseline examination and yearly during follow-up , we administered a 137-item vali date d semiquantitative food-frequency question naire ( 19 ) ; the vali date d Spanish version of the Minnesota Leisure-time Physical Activity Question naire ( 20 ) ; and a 47-item question naire about education , lifestyle , medical history , and medication use . At baseline , trained personnel performed  electrocardiography and anthropometric and blood pressure measurements . Blood pressure  was measured in triplicate by using a vali date d semiautomatic oscillometer with a 5-minute interval between measurements and the participant in a sitting position ( Omron HEM-705CP , Omron , Hoofddorp , the Netherl and s ) . Fasting blood and spot urine were sample d at baseline and follow-up years 1 , 3 , 5 , and 7 . After an overnight fast , tubes for EDTA plasma , citrate plasma , and serum and urine sample s were collected and aliquots were coded and stored at 80C in the central laboratory until analysis . Serum glucose , cholesterol , and triglyceride levels were measured using st and ard enzymatic methods . High-density lipoprotein cholesterol was measured after precipitation with phosphotungstic acid and magnesium chloride . Biomarkers of adherence to the supplemental foods , including urine hydroxytyrosol levels and plasma -linolenic acid proportions , which are reliable biomarkers of EVOO and walnut intake , respectively , were measured in r and om sub sample s of participants during the first 5 years of follow-up ( by gas chromatographymass spectrometry and by gas chromatography , respectively ) . Laboratory technicians were blinded to intervention group . Outcomes and Follow-up Diabetes was a prespecified secondary outcome of the PREDIMED trial . IT was considered to be present at baseline by clinical diagnosis or use of antidiabetic medication . New-onset diabetes during follow-up was diagnosed using the American Diabetes Association criteria , namely fasting plasma glucose levels of 7.0 mmol/L or Summary Two studies were conducted to determine whether adding exercise to a diet programme promotes weight loss or glycaemic control in Type 2 ( non-insulin-dependent ) diabetic subjects . In Study 1 , 25 subjects were r and omly assigned to diet plus moderate exercise or diet plus placebo exercise .  All subjects exercised twice a week as a group and once a week on their own ; the diet plus moderate exercise group walked a 3-mile route at each session while the diet plus placebo exercise group did very low intensity exercises such as stretching and light calisthenics . All subjects followed a calorie-counting diet and were taught behaviour modification strategies . Weight losses and improvements in glycaemic control did not differ significantly between the two treatment groups at the end of the 10-week treatment or at 1-year follow-up . In Study 2 , more extreme conditions were compared : a diet only group and a diet plus exercise group . The diet plus exercise group walked a 3-mile route with the group 3 times/week and once a week on their own , while the diet only group was instructed to maintain their current low level of activity . Both groups received comparable diet and behaviour modification instruction and therapist contacts . The diet plus exercise group had significantly ( p<0.01 ) better weight losses than the diet only condition at the end of the 10 week programme ( −9.3 kg vs −5.6 kg ) and at 1 year follow-up ( −7.9 kg vs −3.8 kg ) . Both groups had similar improvements in glycosylated haemoglobin , but reductions in medication were more frequent and greater in magnitude in the diet plus exercise group . Finally , analyses were conducted collapsing across studies and across treatment groups and comparing subjects who reported low , medium , or high levels of exercise at 1 year . Self-reported exercise was related to weight loss and to improvements in glycosylated haemoglobin , even after adjusting for weight loss . These data suggest that the combination of diet and exercise  improves weight loss and glycaemic control compared to diet only in Type 2 diabetic patients We report the effects of a Mediterranean-style diet , with or without calorie restriction , on biomarkers of aging and oxidative stress in overweight men . 192 men were r and omly assigned to either a Mediterranean-style diet or a conventional diet . The intervention program was based on implementation of a Mediterranean dietary pattern in the overweight group ( MED diet group ) , associated with calorie restriction and increased physical activity in the obese group ( lifestyle group ) . Both groups were compared with participants in two matched control groups ( advice groups ) . After 2 years , there was a significant difference in weight loss between groups , which was −14 kg ( 95 % CI −20 to −8 ) in lifestyle groups and −2.0 kg ( −4.4 to 0 ) in the advice groups , with a difference of −11.9 kg ( CI −19 to −4.7 kg , P < .001 ) ; moreover , there was a significant difference between groups at 2 years for insulin ( P = .04 ) , 8-iso-PGF2α ( P = .037 ) , glucose ( P = .04 ) , and adiponectin ( P = .01 ) . Prolonged adherence to a Mediterranean-style diet , with or without caloric restriction , in overweight or obese men is associated with significant amelioration of multiple risk factors , including a better cardiovascular risk profile , reduced oxidative stress , and improved insulin sensitivity OBJECTIVE To assess the long-term effects of dietary interventions on glycemic control , need for diabetes medications , and remission of type 2 diabetes . RESEARCH DESIGN AND METHODS Originally , in a two-arm trial design , overweight , middle-aged men and women with newly diagnosed type 2 diabetes were r and omized to a low-carbohydrate Mediterranean diet ( LCMD ; n = 108 ) or a low-fat diet ( n = 107 ) . After 4 years , participants who were still free of diabetes medications were further followed up until the primary end point ( need of a diabetic drug ) ; remission of diabetes ( partial or complete ) and changes in weight , glycemic control , and cardiovascular risk factors were also evaluated . RESULTS The primary end point was reached in all participants after a total follow-up of 6.1 years in the low-fat group and 8.1 years in the LCMD group ; median survival time was 2.8 years ( 95 % CI 2.4–3.2 ) and 4.8 years ( 4.3–5.2 ) , respectively . The unadjusted hazard ratio for the overall follow-up was 0.68 ( 0.50–0.89 ; P < 0.001 ) . LCMD participants were more likely to experience any remission ( partial or complete ) , with a prevalence of 14.7 % ( 13.0–16.5 % ) during the first year and 5.0 % ( 4.4–5.6 % ) during year 6 compared with 4.1 % ( 3.1–5.0 % ) at year 1 and 0 % at year 6 in the low-fat diet group . CONCLUSIONS In patients with newly diagnosed type 2 diabetes , an LCMD result ed in a greater reduction of HbA1c levels , higher rate of diabetes remission , and delayed need for diabetes medication compared with a low-fat diet Obesity and type 2 diabetes are inextricably linked . It is therefore unfortunate that insulin , the ultimate treatment to improve glycaemic control in type 2 diabetes , is associated with significant weight gain . The aim of the present investigation was to ascertain whether a dietitian-led intensive lifestyle intervention could attenuate weight gain associated with commencing insulin therapy .  Subjects ( n 50 ) with type 2 diabetes , within 4 weeks of starting insulin therapy  , were r and omly allocated to a control or intervention group . The control group continued with st and ard care whilst the intervention group followed a dietitian-led intensive lifestyle intervention . Over 6 months the control group gained 4.9 ( sd 3.6 ) kg ( P < 0.001 ) , whilst the intervention group maintained their weight ( - 0.6 ( sd 5.1 ) kg ( NS ) . The difference in weight change between the groups was 5.5 kg ( P < 0.001 ) . The control group had significant increases whilst the intervention group had slight decreases in : BMI ( + 1.7 ( sd 1.3 ) kg/m2 ( P < 0.001 ) v. - 0.3 ( sd 2.0 ) kg/m2 ( NS ) ) , waist circumference ( + 5.3 ( sd 5.0 ) cm ( P < 0.001 ) v. - 0.4 ( sd 5.2 ) cm ( NS ) ) and percentage body fat ( + 1.5 ( sd 2.0 ) % ( P < 0.001 ) v. - 0.4 ( sd 2.8 ) % ( NS ) ) . Differences between the groups for these parameters were significant ( P < 0.01 ) . Throughout the study , both groups experienced significant reductions in HbA1c , but only minor changes in blood lipids . The present study demonstrates that weight gain is not an inevitable consequence of starting insulin therapy , but attenuation of the weight gain requires a high level of intervention . The first 6 months to 1 year after initiating insulin therapy provides the ideal ' window of opportunity ' OBJECTIVE To examine if reductions in added sugar intake or increases in fiber intake in response to a 16-week intervention were related to improvements in metabolic outcomes related to type 2 diabetes mellitus risk . DESIGN Secondary analysis of a r and omized control trial . SETTING Intervention classes at a lifestyle laboratory and metabolic measures at the General Clinical Research Center . PARTICIPANTS Fifty-four overweight Latino adolescents ( mean [ SD ] age , 15.5 [ 1 ] years ) . Intervention Sixteen-week study with 3 groups : control , nutrition , or nutrition plus strength training . MAIN OUTCOME MEASURES Body composition by dual-energy x-ray absorptiometry ; visceral adipose tissue by magnetic resonance imaging ; glucose and insulin incremental area under the curve by oral glucose tolerance test ; insulin sensitivity , acute insulin response , and disposition index by intravenous glucose tolerance test ; and dietary intake by 3-day records . RESULTS Fifty-five percent of all participants decreased added sugar intake ( mean decrease , 47 g/d ) and 59 % increased fiber intake ( mean increase , 5 g/d ) , and percentages were similar in all intervention groups , including controls . Those who decreased added sugar intake had an improvement in glucose incremental area under the curve ( -15 % vs + 3 % ; P = .049 ) and insulin incremental area under the curve ( -33 % vs -9 % ; P = .02 ) . Those who increased fiber intake had an improvement in body mass index ( -2 % vs + 2 % ; P = .01 ) and visceral adipose tissue ( -10 % vs no change ; P = .03 ) . CONCLUSIONS Individuals who reduced added sugar intake by the equivalent of 1 can of soda per day or increased fiber intake by the equivalent of a cup of beans showed improvements in key risk factors for type 2 diabetes , specifically in insulin secretion and visceral fat . Improvements occurred independent of group assignment and were equally likely to occur in control group participants Aims /hypothesisThe role of diet in the prevention of diabetes remains uncertain . The aim of this study was to investigate two different dietary aspects , i.e. adherence to the Mediterranean diet and glycaemic load ( GL ) , in relation to diabetes occurrence . Methods We analysed data from the Greek cohort of the population -based European Prospect i ve Investigation into Cancer and Nutrition ( EPIC ) . From a total of 22,295 participants , actively followed for a median of 11.34 years , 2,330 cases of incident type 2 diabetes were recorded . All participants completed a vali date d , interviewer-administered semi-quantitative food frequency question naire at enrolment . From this information , we calculated a ten point Mediterranean diet score ( MDS ) , reflecting adherence to the traditional Mediterranean diet , as well as the dietary GL . We estimated HRs and the corresponding 95 % CIs of diabetes using Cox proportional hazards regression models adjusted for potential confounders . Results A higher MDS was inversely associated with diabetes risk ( HR 0.88 [ 95 % CI 0.78 , 0.99 ] for MDS ≥6 vs MDS ≤3 ) . GL was positively associated with diabetes ( HR 1.21 [ 95 % CI 1.05 , 1.40 ] for the highest vs the lowest GL quartile ) . A significant protection of about 20 % was found for a diet with a high MDS and a low GL . Conclusions /interpretationA low GL diet that also adequately adheres to the principles of the traditional Mediterranean diet may reduce the incidence of type 2 diabetes Lifestyle changes , in particular reducing energy intake , are the cornerstone of current approaches to weight loss and prevention of type 2 diabetes .  However , there is currently no consensus that one dietary regimen is more effective than another for weight loss ( 1 ) or whether particular diets work better for identifiable groups of individuals . There is evidence , however , to suggest that both insulin resistance and insulin secretion play a role in body weight regulation ( 2–12 ) . Therefore , dietary factors such as the dietary glycemic load ( glycemic load = glycemic index [ GI ] × available carbohydrate amount ) that influence these parameters may theoretically interact with subject-specific characteristics of glucose-insulin dynamics to influence the effect of different hypocaloric diets on weight loss or maintenance ( 13,14 ) . Weight loss studies using the concept of the dietary glycemic index or glycemic load have shown conflicting results for heterogeneous groups of individuals ( 15–21 ) . In a 6-month controlled feeding trial in healthy overweight adults with normal glucose tolerance , we tested the hypothesis that individuals with higher insulin secretion lose more weight when r and omized to a low – glycemic load diet compared with a high – glycemic load diet . This study was performed as part of the Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy ( CALERIE ) trial at the Human Nutrition Research Center on Aging at Tufts University with approval from the Tufts-New Engl and Medical Center Human Investigation Review Committee . Written informed consent was obtained from all participants . Healthy women and men aged 24–42
None of the interventions were significantly better than the others in lowering glucose parameters .
The Mediterranean diet reduced HbA1c significantly compared to usual care but not compared to the Palaeolithic diet .
The effect of alterations in dietary practice irrespective of weight loss on glycaemic control can not be concluded from the present review .
BACKGROUND Overweight or obese individuals with type 2 diabetes are encouraged to lose weight for optimal glucose management , yet many find this difficult .
Determining whether alterations in dietary patterns irrespective of weight loss can aid glucose control has not been fully investigated .
METHODS We conducted a systematic review and meta- analysis aim ing to determine the effects of a Mediterranean diet compared to other dietary interventions on glycaemic control irrespective of weight loss .