Advice to follow a low-carbohydrate diet has a favourable impact on low-grade inflammation in type 2 diabetes compared with advice to follow a low-fat diet Effect of low-calorie versus low-carbohydrate ketogenic diet in type 2 diabetes. Decrease of aminotransferase levels in obese women is related to body weight reduction, irrespective of type of diet. Randomization to a low-carbohydrate diet advice improves health related quality of life compared with a low-fat diet at similar weight-loss in Type 2 diabetes mellitus. Two diets with different haemoglobin A1c and antiglycaemic medication effects despite similar weight loss in type 2 diabetes. The effect of a low-carbohydrate, ketogenic diet versus a low-glycemic index diet on glycemic control in type 2 diabetes mellitus In type 2 diabetes, randomisation to advice to follow a low-carbohydrate diet transiently improves glycaemic control compared with advice to follow a low-fat diet producing a similar weight loss Change in food cravings, food preferences, and appetite during a low-carbohydrate and low-fat diet. Year-long weight loss treatment for obese patients with type II diabetes: does including an intermittent very-low-calorie diet improve outcome? Effects on food cravings of a very low calorie diet or a balanced, low calorie diet TCF7L2 genetic variants modulate the effect of dietary fat intake on changes in body composition during a weight-loss intervention. A randomized trial of a low-carbohydrate diet vs orlistat plus a low-fat diet for weight loss. Favorable effects of low-fat and low-carbohydrate dietary patterns on serum leptin, but not adiponectin, among overweight and obese premenopausal women: a randomized trial 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). Long-term effects of advice to consume a high-protein, low-fat diet, rather than a conventional weight-loss diet, in obese adults with Type 2 diabetes: one-year follow-up of a randomised trial The Canadian Trial of Carbohydrates in Diabetes (CCD), a 1-y controlled trial of low-glycemic-index dietary carbohydrate in type 2 diabetes: no effect on glycated hemoglobin but reduction in C-reactive protein. Effects of a Mediterranean-Style Diet on the Need for Antihyperglycemic Drug Therapy in Patients With Newly Diagnosed Type 2 Diabetes Comparative Study of the Effects of a 1-Year Dietary Intervention of a Low-Carbohydrate Diet Versus a Low-Fat Diet on Weight and Glycemic Control in Type 2 Diabetes A high-protein low-fat diet is more effective in improving blood pressure and triglycerides in calorie-restricted obese individuals with newly diagnosed type 2 diabetes Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus An Online Intervention Comparing a Very Low-Carbohydrate Ketogenic Diet and Lifestyle Recommendations Versus a Plate Method Diet in Overweight Individuals With Type 2 Diabetes: A Randomized Controlled Trial A randomized controlled trial of 130 g/day low-carbohydrate diet in type 2 diabetes with poor glycemic control. Liver Fat Is Reduced by an Isoenergetic MUFA Diet in a Controlled Randomized Study in Type 2 Diabetic Patients
Abstract Background . Inflammation may play an important role in type 2 diabetes . It has been proposed that dietary strategies can modulate inflammatory activity . Methods . We investigated the effects of diet on inflammation in type 2 diabetes by comparing a traditional low-fat diet ( LFD ) with a low-carbohydrate diet ( LCD ) .  Patients with type 2 diabetes were r and omized to follow either LFD aim ing for 55–60 energy per cent ( E% ) from carbohydrates ( n = 30 ) or LCD aim ing for 20 E% from carbohydrates ( n = 29 ) . Plasma was collected at baseline and after 6 months . C-reactive protein ( CRP ) , interleukin-1 receptor antagonist ( IL-1Ra ) , IL-6 , tumour necrosis factor receptor ( TNFR ) 1 and TNFR2 were determined . Results . Both LFD and LCD led to similar reductions in body weight , while beneficial effects on glycaemic control were observed in the LCD group only . After 6 months , the levels of IL-1Ra and IL-6 were significantly lower in the LCD group than in the LFD group , 978 ( 664–1385 ) versus 1216 ( 974–1822 ) pg/mL and 2.15 ( 1.65–4.27 ) versus 3.39 ( 2.25–4.79 ) pg/mL , both P < 0.05 . Conclusions . To conclude , advice to follow LCD or LFD had similar effects on weight reduction while effects on inflammation differed . Only LCD was found significantly to improve the sub clinical inflammatory state in type 2 diabetes . Trial registration : Clinical Trials.gov identifier : NCT01005498 OBJECTIVE Effective diabetic management requires reasonable weight control . Previous studies from our laboratory have shown the beneficial effects of a low-carbohydrate ketogenic diet ( LCKD ) in patients with type 2 diabetes after its long term administration . Furthermore , it favorably alters the cardiac risk factors even in hyperlipidemic obese subjects . These studies have indicated that , in addition to decreasing body weight and improving glycemia , LCKD can be effective in decreasing antidiabetic medication dosage . Similar to the LCKD , the conventional low-calorie , high nutritional value diet is also used for weight loss . The purpose of this study was to underst and the beneficial effects of LCKD compared with the low-calorie diet ( LCD ) in improving glycemia . METHODS Three hundred and sixty-three overweight and obese participants were recruited from the Al-Shaab Clinic for a 24-wk diet intervention trial ; 102 of them had type 2 diabetes . The participants were advised to choose LCD or LDKD , depending on their preference . Body weight , body mass index , changes in waist circumference , blood glucose level , changes in hemoglobin and glycosylated hemoglobin , total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , triglycerides , uric acid , urea and creatinine were determined before and at 4 , 8 , 12 , 16 , 20 , and 24 wk after the administration of the LCD or LCKD . The initial dose of some antidiabetic medications was decreased to half and some were discontinued at the beginning of the dietary program in the LCKD group . Dietary counseling and further medication adjustment were done on a biweekly basis . RESULTS The LCD and LCKD had beneficial effects on all the parameters examined . Interestingly , these changes were more significant in subjects who were on the LCKD as compared with those on the LCD . Changes in the level of creatinine were not statistically significant . CONCLUSION This study shows the beneficial effects of a ketogenic diet over the conventional LCD in obese diabetic subjects . The ketogenic diet appears to improve glycemic control . Therefore , diabetic patients on a ketogenic diet should be under strict medical supervision because the LCKD can significantly lower blood glucose levels OBJECTIVE To evaluate the efficacy of low carbohydrate diet ( LCD ) as compared with low fat diet ( LFD ) to decrease aminotransferase levels in obese women with nonalcoholic fatty liver disease . MATERIAL AND METHODS A total of 59 women were r and omly enrolled in a non-controlled clinical intervention study to receive either LCD or LFD during six months . Apparently healthy non-pregnant obese women aged 20 to 65 years were eligible to participate . Previous diagnosis of hepatic disease , serum creatinine level ≥ 1.5 mg/dL , severe life-limiting medical illness , pregnancy , active participation in other dietary program , use of weight loss drugs , or alcohol consumption ≥ 30 g per day were exclusion criteria . RESULTS A total of 31 obese women who received LCD were compared with 28 women allocated in the LFD group . There were 3 ( LCD group ) and 2 ( LFD group ) women with lost of follow-up . No differences in the proportion of type 2 diabetes , hypertension and hyperlipidemia were noted between women in the LCD and LFD groups . At end of follow-up , there were not significant statistical differences in the anthropometric and biochemical characteristics between women in both groups . The weight loss was 5.7 and 5.5 % for women in the LCD LFD groups . Although the decrease of AST ( 31.7 and 22.4 % ) and ALT ( 41 and 33.3 % ) levels was more elevated in the women of LCD group , as compared with the LFD group , there were not significant statistical differences . CONCLUSIONS Our results show that weight loss , irrespective of the type of diet , reduces aminotransferase levels in obese women with NAFLD AIMS To compare the effects on health-related quality of life ( HRQoL ) of a 2-year intervention with a low-fat diet ( LFD ) or a low-carbohydrate diet ( LCD ) based on four group-meetings to achieve compliance . To describe different aspects of taking part in the intervention following the LFD or LCD . METHODS Prospect i ve , r and omized trial of 61 adults with Type 2 diabetes mellitus . The SF-36 question naire was used at baseline , 6 , 12 and 24 months . Patients on LFD aim ed for 55 - 60 energy percent ( E% ) and those on LCD for 20 E% from carbohydrates . The patients were interviewed about their experiences of the intervention . RESULTS Mean body-mass-index was 32.7 ± 5.4 kg/m(2 ) at baseline . Weight-loss did not differ between groups and was maximal at 6 months , LFD : -3.99 ± 4.1 kg , LCD : -4.31 ± 3.6 kg ( p<0.001 within groups ) . There was an increase in the physical component score of SF-36 from 44.1 ( 10.0 ) to 46.7 ( 10.5 ) at 12 months in the LCD group ( p < 0.009 ) while no change occurred in the LFD group ( p < 0.03 between groups ) . At 12 months the physical function , bodily pain and general health scores improved within the LCD group ( p values 0.042 - 0.009 ) while there was no change within the LFD group . CONCLUSIONS Weight-changes did not differ between the diet groups while improvements in HRQoL only occurred after one year during treatment with LCD . No changes of HRQoL occurred in the LFD group in spite of a similar reduction in body weight We analysed participants with type 2 diabetes ( n = 46 ) within a larger weight loss trial ( n = 146 ) who were r and omized to 48 weeks of a low-carbohydrate diet ( LCD ; n = 22 ) or a low-fat diet + orlistat ( LFD + O ; n = 24 ) . At baseline , mean body mass index ( BMI ) was 39.5 kg/m(2 ) ( s.d . 6.5 ) and haemoglobin A1c ( HbA1c ) 7.6 % ( s.d . 1.3 ) . Although the interventions reduced BMI similarly ( LCD -2.4 kg/m(2 ) ; LFD + O -2.7 kg/m(2 ) , p = 0.7 ) , LCD led to a relative improvement in HbA1c : -0.7 % in LCD versus + 0.2 % in LFD + O [ difference -0.8 % , 95 % confidence interval ( CI ) = -1.6 , -0.02 ; p = 0.045 ] . LCD also led to a greater reduction in antiglycaemic medications using a novel medication effect score ( MES ) based on medication potency and total daily dose ; 70.6 % of LCD versus 30.4 % LFD + O decreased their MES by ≥50 % ( p = 0.01 ) . Lowering dietary carbohydrate intake demonstrated benefits on glycaemic control beyond its weight loss effects , while at the same time lowering antiglycaemic medication requirements Objective Dietary carbohydrate is the major determinant of postpr and ial glucose levels , and several clinical studies have shown that low-carbohydrate diets improve glycemic control . In this study , we tested the hypothesis that a diet lower in carbohydrate would lead to greater improvement in glycemic control over a 24-week period in patients with obesity and type 2 diabetes mellitus . Research design and methods Eighty-four community volunteers with obesity and type 2 diabetes were r and omized to either a low-carbohydrate , ketogenic diet ( < 20 g of carbohydrate daily ; LCKD ) or a low-glycemic , reduced-calorie diet ( 500 kcal/day deficit from weight maintenance diet ; LGID ) . Both groups received group meetings , nutritional supplementation , and an exercise recommendation . The main outcome was glycemic control , measured by hemoglobin A1c . Results Forty-nine ( 58.3 % ) participants completed the study . Both interventions led to improvements in hemoglobin A1c , fasting glucose , fasting insulin , and weight loss . The LCKD group had greater improvements in hemoglobin A1c ( -1.5 % vs. -0.5 % , p = 0.03 ) , body weight ( -11.1 kg vs. -6.9 kg , p = 0.008 ) , and high density lipoprotein cholesterol ( + 5.6 mg/dL vs. 0 mg/dL , p < 0.001 ) compared to the LGID group . Diabetes medications were reduced or eliminated in 95.2 % of LCKD vs. 62 % of LGID participants ( p < 0.01 ) . Conclusion Dietary modification led to improvements in glycemic control and medication reduction/elimination in motivated volunteers with type 2 diabetes . The diet lower in carbohydrate led to greater improvements in glycemic control , and more frequent medication reduction/elimination than the low glycemic index diet . Lifestyle modification using low carbohydrate interventions is effective for improving and reversing type 2 diabetes Aims /hypothesisThe study aim ed to compare the effects of a 2 year intervention with a low-fat diet ( LFD ) or a low-carbohydrate diet ( LCD ) , based on four group meetings to achieve compliance . Methods This was a prospect i ve r and omised parallel trial involving 61 adults with type 2 diabetes consecutively recruited in primary care and r and omised by drawing ballots . Patients that did not speak Swedish could not be recruited . The primary outcomes in this non-blinded study were weight and HbA1c . Patients on the LFD aim ed for 55–60 energy per cent ( E% ) and those on LCD for 20 E% from carbohydrate . Results The mean BMI and HbA1c of the participants were 32.7 ± 5.4 kg/m2 and 57.0 ± 9.2 mmol/mol , respectively . No patients were lost to follow-up . Weight loss did not differ between groups and was maximal at 6 months : LFD −3.99 ± 4.1 kg ( n = 31 ) ; LCD −4.31 ± 3.6 kg ( n = 30 ) ; p < 0.001 within groups . At 24 months , patients on the LFD had lost −2.97 ± 4.9 kg and those on LCD −2.34 ± 5.1 kg compared with baseline ( p = 0.002 and p = 0.020 within groups , respectively ) . HbA1c fell in the LCD group only ( LCD at 6 months −4.8 ± 8.3 mmol/mol , p = 0.004 , at 12 months −2.2 ± 7.7 mmol/mol , p = 0.12 ; LFD at 6 months −0.9 ± 8.8 mmol/mol , p = 0.56 ) . At 6 months , HDL-cholesterol had increased with the LCD ( from 1.13 ± 0.33 mmol/l to 1.25 ± 0.47 mmol/l , p = 0.018 ) while LDL-cholesterol did not differ between groups . Insulin doses were reduced in the LCD group ( 0 months , LCD 42 ± 65 E , LFD 39 ± 51 E ; 6 months , LCD 30 ± 47 E , LFD 38 ± 48 E ; p = 0.046 for between-group change ) . Conclusions /interpretationWeight changes did not differ between the diet groups , while insulin doses were reduced significantly more with the LCD at 6 months , when compliance was good . Thus , aim ing for 20 % of energy intake from carbohydrates is safe with respect to cardiovascular risk compared with the traditional LFD and this approach could constitute a treatment alternative . Trial registration : Clinical Trials.gov NCT01005498 Funding : University Hospital of Linköping Research Funds , Linköping University , the County Council of Östergötl and , and the Diabetes Research Centre of Linköping The study objective was to evaluate the effect of prescribing a low-carbohydrate diet ( LCD ) and a low-fat diet ( LFD ) on food cravings , food preferences , and appetite .  Obese adults were r and omly assigned to a LCD ( n = 134 ) or a LFD ( n = 136 ) for 2 years . Cravings for specific types of foods ( sweets , high-fats , fast-food fats , and carbohydrates/starches ) ; preferences for high-sugar , high-carbohydrate , and low-carbohydrate/high-protein foods ; and appetite were measured during the trial and evaluated during this secondary analysis of trial data . Differences between the LCD and LFD on change in outcome variables were examined with mixed linear models . Compared to the LFD , the LCD had significantly larger decreases in cravings for carbohydrates/starches and preferences for high-carbohydrate and high-sugar foods . The LCD group reported being less bothered by hunger compared to the LFD group . Compared to the LCD group , the LFD group had significantly larger decreases in cravings for high-fat foods and preference for low-carbohydrate/high-protein foods . Men had larger decreases in appetite ratings compared to women . Prescription of diets that promoted restriction of specific types of foods result ed in decreased cravings and preferences for the foods that were targeted for restriction . The results also indicate that the LCD group was less bothered by hunger compared to the LFD group and that men had larger reductions in appetite compared to women PURPOSE To evaluate a year-long behavioral weight control program , used with and without an intermittent very-low-calorie diet ( VLCD ) in the treatment of type II diabetes mellitus . PATIENTS AND METHODS Subjects ( n = 93 ) were r and omly assigned to 50-week treatment programs that used either a balanced low-calorie diet ( LCD ) of 1,000 to 1,000 kilocalories ( kcal ) per day throughout or included 2 12-week periods of a VLCD of 400 to 500 kcal per day alternating with the balanced LCD .  Weight , glycemic control , blood pressure , and lipids were assessed at baseline , at the end of the year-long treatment , and at 2-year follow-up . RESULTS Subjects in the VLCD program lost significantly more weight than did LCD subjects at the end of the 50-week program ( 14.2 kg versus 10.5 kg ; P = 0.057 ) and remained off diabetes medication longer ( P < 0.05 ) . These benefits of the VLCD were due primarily to the first 12 weeks of the diet ; the second diet maintained , but did not increase , these effects . Subjects in both groups experienced marked improvements in glycemic control and cardiovascular risk factors over the year-long program , but attendance declined in the latter weeks of treatment and weight was regained . There was also marked recidivism in both groups in the year following treatment . CONCLUSIONS The intermittent VLCD improved weight loss and glycemic control , but these effects were quite modest and do not appear to justify the clinical use of an intermittent VLCD . Moreover , lengthening treatment to a full year did not prevent relapse . Thus , further research is needed to develop a successful approach to long-term weight control It is commonly believed that dieting and the restriction of specific types of foods produces cravings for these foods . This study , therefore , compared changes in self-reported cravings experienced by 93 obese subjects with Type II diabetes who were r and omly assigned to behavioral treatment programmes which used either : ( a ) a balanced , low-calorie diet ( LCD ) of 1000 - 1200 kcal/day throughout , with all foods allowed in moderation , or ( b ) a programme which included a 12-week period of a very low calorie diet ( VLCD ) , where intake was restricted to 400 kcal/day with only lean meat , fish , or fowl allowed . There were significant decreases in cravings for all types of foods over the 20 weeks of the study for both the VLCD and the LCD conditions . The decreases in cravings were particularly pronounced for the VLCD condition for low-fat , high-protein foods ( the only foods allowed on the VLCD ) and for complex carbohydrates , especially grains ( one of the types of foods prohibited on this diet ) . There was no evidence to support the belief that restricting intake of certain foods leads to increased craving for these foods or that the magnitude of weight loss is related to food cravings BACKGROUND TCF7L2 gene variants have been associated with increased risk of  type 2 diabetes and higher adiposity .  Observational studies and short-term trials have suggested that macronutrients may modify these effects . However , to our knowledge , this has yet to be verified in long-term interventions . OBJECTIVE In a long-term intervention setting , we investigated the effects of TCF7L2 polymorphisms rs7903146 and rs12255372 and dietary total fat on changes in body composition and subsequent glycemic control . DESIGN Data were analyzed for 591 participants in the Preventing Overweight Using Novel Dietary Strategies ( Pounds Lost ) trial , which is a 2-y weight-loss r and omized clinical trial of diets that differed in macronutrient proportions . Adjusted means for changes in body composition at 6 and 24 mo were obtained for gene main effects and interactions with a low-fat diet ( 20 % from energy ) compared with a high-fat diet ( 40 % from energy ) . Interactions with protein and carbohydrate intakes were also tested . Predicted changes in glycemic control from changes in adiposity were determined by genotype and diet type . RESULTS Significant interactions were observed for rs12255372 TT ( risk genotype ) and fat intake for changes in BMI , total fat mass , and trunk fat mass ( all P/q < 0.05 ) at 6 mo , with nonsignificant larger decreases for TT carriers on a low-fat diet . No significant associations were observed at 24 mo or for other macronutrients . Changes in body composition for TT carriers predicted reductions in plasma glucose and insulin only on the low-fat diet . CONCLUSIONS Individuals with the TCF7L2 rs12255372 risk genotype may reduce body adiposity by consuming a diet lower in total fat . These reductions may induce better glycemic control for such individuals predisposed to type 2 diabetes . The Pounds Lost trial was registered at clinical trials.gov as NCT00072995 BACKGROUND Two potent weight loss therapies , a low-carbohydrate , ketogenic diet ( LCKD ) and orlistat therapy combined with a low-fat diet ( O + LFD ) , are available to the public but , to our knowledge , have never been compared . METHODS Overweight or obese out patients ( n = 146 ) from the Department of Veterans Affairs primary care clinics in Durham , North Carolina , were r and omized to either LCKD instruction ( initially , < 20 g of carbohydrate daily ) or orlistat therapy , 120 mg orally 3 times daily , plus low-fat diet instruction ( < 30 % energy from fat , 500 - 1000 kcal/d deficit ) delivered at group meetings over 48 weeks . Main outcome measures were body weight , blood pressure , fasting serum lipid , and glycemic parameters . RESULTS The mean age was 52 years and mean body mass index was 39.3 ( calculated as weight in kilograms divided by height in meters squared ) ; 72 % were men , 55 % were black , and 32 % had type 2 diabetes mellitus . Of the study participants , 57 of the LCKD group ( 79 % ) and 65 of the O + LFD group ( 88 % ) completed measurements at 48 weeks . Weight loss was similar for the LCKD ( expected mean change , -9.5 % ) and the O + LFD ( -8.5 % ) ( P = .60 for comparison ) groups . The LCKD had a more beneficial impact than O + LFD on systolic ( -5.9 vs 1.5 mm Hg ) and diastolic ( -4.5 vs 0.4 mm Hg ) blood pressures ( P < .001 for both comparisons ) . High-density lipoprotein cholesterol and triglyceride levels improved similarly within both groups . Low-density lipoprotein cholesterol levels improved within the O + LFD group only , whereas glucose , insulin , and hemoglobin A(1c ) levels improved within the LCKD group only ; comparisons between groups , however , were not statistically significant . CONCLUSION In a sample of medical out patients , an LCKD led to similar improvements as O + LFD for weight , serum lipid , and glycemic parameters and was more effective for lowering blood pressure . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00108524 Purpose The most effective dietary pattern for breast cancer prevention has been greatly debated in recent years . Studies have examined hypocaloric diets , with particular emphasis on macronutrient composition , yielding inconclusive data . The objective of this study was to examine the effects of calorie-restricted low-fat and low-carbohydrate diets ( LFD and LCD , respectively ) on circulating adipokines among overweight and obese premenopausal women . Methods Seventy-nine overweight and obese premenopausal women were r and omized to either LFD or LCD , with increased physical activity , for 52 weeks . Serum adiponectin , leptin and the adiponectin-to-leptin ratio ( A/L ) were measured at baseline , and at weeks 34 and 52 to assess intervention effects . Results While there were no significant changes in serum adiponectin concentrations following the LCD and LFD interventions , leptin concentrations significantly decreased by week 34 of the intervention period ( LCD : 35.3 % , P = 0.004 ; LFD : 30.0 % , P = 0.01 ) , with no difference by intervention arm . At week 52 , these reductions were statistically non-significant , indicating a return to baseline levels by the end of the intervention . While there were non-significant increases in the A/L ratio following the LCD and LFD intervention arms , the overall trend , across groups , was marginally significant ( P = 0.05 ) with increases of 16.2 % and 35.1 % at weeks 34 and 52 , respectively . Conclusions These findings suggest that caloric-restricted LCD and LFD dietary patterns favorably modify leptin and possibly the A/L ratio , and lend support to the hypothesis that these interventions may be effective for obesity-related breast cancer prevention through their effects on biomarkers involved in metabolic pathways . Trial registration Clinical Trial Registration Number : NCT01559194 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 Aims /hypothesisThis study compared the long-term weight loss and health outcomes at 1-year follow-up , after a 12-week intensive intervention consisting of two low-fat , weight-loss diets , which differed in protein content . Methods We r and omly assigned 66 obese patients ( BMI : 27–40 kg/m2 ) with Type 2 diabetes to either a low-protein ( 15 % protein , 55 % carbohydrate ) or high-protein diet ( 30 % protein , 40 % carbohydrate ) for 8 weeks of energy restriction ( ~6.7 MJ/day ) and 4 weeks of energy balance . Subjects were asked to maintain the same dietary pattern for a further 12 months of follow-up . Results The study was completed by 38 of the subjects , with equal dropouts in each group . At Week 64 , weight reductions against baseline were −2.2±1.1 kg ( low protein ) and −3.7±1.0 kg ( high protein ) , p<0.01 , with no diet effect . Fat mass was not different from baseline in either group . At Week 12 , both diets reduced systolic and diastolic blood pressure by 6 and 3 mm Hg respectively , but blood pressure increased more with weight regain during follow-up in the low-protein group ( p≤0.04 ) . At Week 64 , both diets significantly increased HDL cholesterol and lowered C-reactive protein concentrations . There was no difference in the urinary urea : creatinine ratio at baseline between the two groups , but this ratio increased at Week 12 ( in the high-protein group only , p<0.001 , diet effect ) , remaining stable during follow-up in both diets . Conclusions /interpretationA high-protein weight-reduction diet may in the long term have a more favourable cardiovascular risk profile than a low-protein diet with similar weight reduction in people with Type 2 diabetes BACKGROUND The optimal source and amount of dietary carbohydrate for managing type 2 diabetes ( T2DM ) are unknown . OBJECTIVE We aim ed to compare the effects of altering the glycemic index or the amount of carbohydrate on glycated hemoglobin ( HbA1c ) , plasma glucose , lipids , and C-reactive protein ( CRP ) in T2DM patients . DESIGN Subjects with T2DM managed by diet alone ( n=162 ) were r and omly assigned to receive high-carbohydrate , high-glycemic-index ( high-GI ) , high-carbohydrate , low-glycemic-index ( low-GI ) , or low-carbohydrate , high-monounsaturated-fat ( low-CHO ) diets for 1 y. RESULTS The high-GI , low-GI , and low-CHO diets contained , respectively , 47 % , 52 % , and 39 % of energy as carbohydrate and 31 % , 27 % , and 40 % of energy as fat ; they had GIs of 63 , 55 , and 59 , respectively . Body weight and HbA1c did not differ significantly between diets . Fasting glucose was higher ( P=0.041 ) , but 2-h postload glucose was lower ( P=0.010 ) after 12 mo of the low-GI diet . With the low-GI diet , overall mean triacylglycerol was 12 % higher and HDL cholesterol 4 % lower than with the low-CHO diet ( P<0.05 ) , but the difference in the ratio of total to HDL cholesterol disappeared by 6 mo ( time x diet interaction , P=0.044 ) . Overall mean CRP with the low-GI diet , 1.95 mg/L , was 30 % less than that with the high-GI diet , 2.75 mg/L ( P=0.0078 ) ; the concentration with the low-CHO diet , 2.35 mg/L , was intermediate . CONCLUSIONS In subjects with T2DM managed by diet alone with optimal glycemic control , long-term HbA1c was not affected by altering the GI or the amount of dietary carbohydrate . Differences in total : HDL cholesterol among diets had disappeared by 6 mo . However , because of sustained reductions in postpr and ial glucose and CRP , a low-GI diet may be preferred for the dietary management of 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 OBJECTIVE To compare the effects of a 1-year intervention with a low-carbohydrate and a low-fat diet on weight loss and glycemic control in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS This study is a r and omized clinical trial of 105 overweight adults with type 2 diabetes . Primary outcomes were weight and A1C . Secondary outcomes included blood pressure and lipids . Outcome measures were obtained at 3 , 6 , and 12 months . RESULTS The greatest reduction in weight and A1C occurred within the first 3 months . Weight loss occurred faster in the low-carbohydrate group than in the low-fat group ( P = 0.005 ) , but at 1 year a similar 3.4 % weight reduction was seen in both dietary groups . There was no significant change in A1C in either group at 1 year . There was no change in blood pressure , but a greater increase in HDL was observed in the low-carbohydrate group ( P = 0.002 ) . CONCLUSIONS Among patients with type 2 diabetes , after 1 year a low-carbohydrate diet had effects on weight and A1C similar to those seen with a low-fat diet . There was no significant effect on blood pressure , but the low-carbohydrate diet produced a greater increase in HDL cholesterol Background / Objectives : There is controversy over dietary protein 's effects on cardiovascular disease risk factors in diabetic subjects . It is unclear whether observed effects are due to increased protein or reduced carbohydrate content of the consumed diets . The aim of this study was to compare the effects of two diets differing in protein to fat ratios on cardiovascular disease risk factors . Subjects/ Methods : A total of 17 obese ( body mass index ( BMI ) ranging from 31 to 45 kg/m2 ) volunteers with type 2 diabetes ( DM2 ) , aged 46±3 years , consumed two diets , each for 4 weeks , with 3 weeks of washout period in a r and om , blind , crossover design . The diets were : ( 1 ) a high-protein low-fat diet ( HP – LF , with 30 % protein , 50 % carbohydrates and 20 % fat ) and ( 2 ) a low-protein high-fat diet ( LP – HF , with 15 % protein , 50 % carbohydrates and 35 % fat ) . Their effects on fasting glycemic control , lipid levels and blood pressure , and on postpr and ial glucose and insulin responses after a st and ard test meal at the beginning and end of each dietary intervention were analyzed . Results : Both diets were equally effective in promoting weight loss and fat loss and in improving fasting glycemic control , total cholesterol and low-density lipoprotein ( LDL ) cholesterol , but the HP – LF diet decreased to a greater extent triglyceride ( TG ) levels ( P=0.04 ) when compared with the LP – HF diet . HP – LF diet improved significantly both systolic and diastolic blood pressure when compared with the LP – HF diet ( P<0.001 and P<0.001 , respectively ) . No differences were observed in postpr and ial glucose and insulin responses . Conclusions : A protein to fat ratio of 1.5 in diets significantly improves blood pressure and TG concentrations in obese individuals with DM2 Brackground : The safety and tolerability of very low-calorie-ketogenic ( VLCK ) diets are a current concern in the treatment of obese type 2 diabetes mellitus ( T2DM ) patients . Objective : Evaluating the short-term safety and tolerability of a VLCK diet ( < 50 g of carbohydrate daily ) in an interventional weight loss program including lifestyle and behavioral modification support ( Diaprokal Method ) in subjects with T2DM . Methods : Eighty-nine men and women , aged between 30 and 65 years , with T2DM and body mass index between 30 and 35 kg m−2 participated in this prospect i ve , open-label , multi-centric r and omized clinical trial with a duration of 4 months . Forty-five subjects were r and omly assigned to the interventional weight loss ( VLCK diet ) , and 44 to the st and ard low-calorie diet . Results : No significant differences in the laboratory safety parameters were found between the two study groups . Changes in the urine albumin-to-creatinine ratio in VLCK diet were not significant and were comparable to control group . Creatinine and blood urea nitrogen did not change significantly relative to baseline nor between groups . Weight loss and reduction in waist circumference in the VLCK diet group were significantly larger than in control subjects ( both P<0.001 ) . The decline in HbA1c and glycemic control was larger in the VLCK diet group ( P<0.05 ) . No serious adverse events were reported and mild AE in the VLCK diet group declined at last follow-up . Conclusions : The interventional weight loss program based on a VLCK diet is most effective in reducing body weight and improvement of glycemic control than a st and ard hypocaloric diet with safety and good tolerance for T2DM patients Background Type 2 diabetes is a prevalent , chronic disease for which diet is an integral aspect of treatment . In our previous trial , we found that recommendations to follow a very low-carbohydrate ketogenic diet and to change lifestyle factors ( physical activity , sleep , positive affect , mindfulness ) helped overweight people with type 2 diabetes or prediabetes  improve glycemic control and lose weight . This was an in-person intervention , which could be a barrier for people without the time , flexibility , transportation , social support , and /or financial re sources to attend . Objective The aim was to determine whether an online intervention based on our previous recommendations ( an ad libitum very low-carbohydrate ketogenic diet with lifestyle factors ; “ intervention ” ) or an online diet program based on the American Diabetes Associations ’ “ Create Your Plate ” diet ( “ control ” ) would improve glycemic control and other health outcomes among overweight individuals with type 2 diabetes . Methods In this pilot feasibility study , we r and omized overweight adults ( body mass index ≥25 ) with type 2 diabetes ( glycated hemoglobin [ HbA1c ] 6.5%-9.0 % ) to a 32-week online intervention based on our previous recommendations ( n=12 ) or an online diet program based around a plate method diet ( n=13 ) to assess the impact of each intervention on glycemic control and other health outcomes . Primary and secondary outcomes were analyzed by mixed-effects linear regression to compare outcomes by group . Results At 32 weeks , participants in the intervention group reduced their HbA1c levels more ( estimated marginal mean [ EMM ] –0.8 % , 95 % CI –1.1 % to –0.6 % ) than participants in the control group ( EMM –0.3 % , 95 % CI –0.6 % to 0.0 % ; P=.002 ) . More than half of the participants in the intervention group ( 6/11 , 55 % ) lowered their HbA1c to less than 6.5 % versus 0 % ( 0/8 ) in the control group ( P=.02 ) . Participants in the intervention group lost more weight ( EMM –12.7 kg , 95 % CI –16.1 to –9.2 kg ) than participants in the control group ( EMM –3.0 kg , 95 % CI –7.3 to 1.3 kg ; P<.001 ) . A greater percentage of participants lost at least 5 % of their body weight in the intervention ( 10/11 , 90 % ) versus the control group ( 2/8 , 29 % ; P=.01 ) . Participants in the intervention group lowered their triglyceride levels ( EMM –60.1 mg/dL , 95 % CI –91.3 to –28.9 mg/dL ) more than participants in the control group ( EMM –6.2 mg/dL , 95 % CI –46.0 to 33.6 mg/dL ; P=.01 ) . Dropout was 8 % ( 1/12 ) and 46 % ( 6/13 ) for the intervention and control groups , respectively ( P=.07 ) . Conclusions Individuals with type 2 diabetes improved their glycemic control and lost more weight after being r and omized to a very low-carbohydrate ketogenic diet and lifestyle online program rather than a conventional , low-fat diabetes diet online program . Thus , the online delivery of these very low-carbohydrate ketogenic diet and lifestyle recommendations may allow them to have a wider reach in the successful self-management of type 2 diabetes . Trial Registration Clinical Trials.gov NCT01967992 ; https:// clinical trials.gov/ct2/show/NCT01967992 ( Archived by WebCite at http://www.webcitation.org/6o0fI9Mkq BACKGROUND & AIMS The usefulness of low-carbohydrate diet ( LCD ) for Japanese patients with type 2 diabetes mellitus ( T2DM ) has not been fully investigated . Therefore , we compared the effectiveness and safety of LCD with calorie restricted diet ( CRD ) . METHODS This prospect i ve , r and omized , open-label , comparative study included 66 T2DM patients with HbA1c > 7.5 % even after receiving repeated education programs on CRD .  They were r and omly allocated to either the 130g/day LCD group ( n = 33 ) or CRD group ( n = 33 ) . Patients received personal nutrition education of CRD or LCD for 30 min at baseline , 1 , 2 , 4 , and 6 months . Patients of the CRD group were advised to maintain the intake of calories and balance of macronutrients ( 28 × ideal body weight calories per day ) . Patients of the LCD group were advised to maintain the intake of 130 g/day carbohydrate without other specific restrictions . Several parameters were assessed at baseline and 6 months after each intervention . The primary endpoint was a change in HbA1c level from baseline to the end of the study . RESULTS At baseline , BMI and HbA1c were 26.5 ( 24.6 - 30.1 ) and 8.3 ( 8.0 - 9.3 ) , and 26.7 ( 25.0 - 30.0 ) kg/m2 and 8.0 ( 7.6 - 8.9 ) % , in the CRD and LCD , respectively . At the end of the study , HbA1c decreased by -0.65 ( -1.53 to -0.10 ) % in the LCD group , compared with 0.00 ( -0.68 to 0.40 ) % in the CRD group ( p < 0.01 ) . Also , the decrease in BMI in the LCD group [ -0.58 ( -1.51 to -0.16 ) kg/m2 ] exceeded that observed in the CRD group ( p = 0.03 ) . CONCLUSIONS Our study demonstrated that 6-month 130 g/day LCD reduced HbA1c and BMI in poorly controlled Japanese patients with T2DM . LCD is a potentially useful nutrition therapy for Japanese patients who can not adhere to CRD . This trial was registered at http://www.umin.ac.jp/english/ ( University Hospital Medical Information Network : study ID number 000010663 ) OBJECTIVE To evaluate the effects of qualitative dietary changes and the interaction with aerobic exercise training on liver fat content independent of weight loss in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS With use of a factorial 2 × 2 r and omized parallel-group design , 37 men and 8 women , aged 35–70 years , with type 2 diabetes in satisfactory blood glucose control on diet or diet plus metformin treatment  were assigned to one of the following groups for an 8-week period : 1 ) high-carbohydrate/high-fiber/low – glycemic index diet ( CHO/fiber group ) , 2 ) high-MUFA diet ( MUFA group ) , 3 ) high-carbohydrate/high-fiber/low – glycemic index diet plus physical activity program ( CHO/fiber+Ex group ) , and 4 ) high-MUFA diet plus physical activity program ( MUFA+Ex group ) . Before and after intervention , hepatic fat content was measured by 1H NMR . RESULTS Dietary compliance was optimal and body weight remained stable in all groups . Liver fat content decreased more in MUFA ( −29 % ) and MUFA+Ex ( −25 % ) groups than in CHO/fiber ( −4 % ) and CHO/fiber+Ex groups ( −6 % ) . Two-way repeated- measures ANOVA , including baseline values as covariate , showed a significant effect on liver fat content for diet ( P = 0.006 ) , with no effects for exercise training ( P = 0.789 ) or diet-exercise interaction ( P = 0.712 ) . CONCLUSIONS An isocaloric diet enriched in MUFA compared with a diet higher in carbohydrate and fiber was associated with a clinical ly relevant reduction of hepatic fat content in type 2 diabetic patients independent of an aerobic training program and should be considered for the nutritional management of hepatic steatosis in people with type 2 diabetes
The longest trial intervention studies did not show a difference in weight change .
This review shows that there are no consistent differences in weight and A1C changes over the long-term treatment with LCD and LFD , UCD or LGID
INTRODUCTION Low carbohydrate diets ( LCD ) have shown beneficial effects on short-term weight reduction programs for obese individuals without diabetes , but the long-term evidence of efficacy on individuals with type 2 diabetes is not conclusive .
OBJECTIVE To evaluate , the effectiveness of 12 or more weeks of LCD compared to Low Fat Diet ( LFD ) , Usual Care Diet ( UCD ) or Low Glycemic Index Diet ( LGID ) on weight reduction and AIC on type 2 diabetes individuals .