BACKGROUNDObesity is a chronic disease with serious health consequences, but weight loss is difficult to maintain through lifestyle intervention alone. Liraglutide, a glucagonlike peptide-1 analogue, has been shown to have potential benefit for weight management at a once-daily dose of 3.0 mg, injected subcutaneously. METHODSWe conducted a 56-week, double-blind trial involving 3731 patients who did not have type 2 diabetes and who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of at least 30 or a BMI of at least 27 if they had treated or untreated dyslipidemia or hypertension. We randomly assigned patients in a 2:1 ratio to receive once-daily subcutaneous injections of liraglutide at a dose of 3.0 mg (2487 patients) or placebo (1244 patients); both groups received counseling on lifestyle modification. The coprimary end points were the change in body weight and the proportions of patients losing at least 5% and more than 10% of their initial body weight. RESULTSAt baseline, the mean (±SD) age of the patients was 45.1±12.0 years, the mean weight was 106.2±21.4 kg, and the mean BMI was 38.3±6.4; a total of 78.5% of the patients were women and 61.2% had prediabetes. At week 56, patients in the liraglutide group had lost a mean of 8.4±7.3 kg of body weight, and those in the placebo group had lost a mean of 2.8±6.5 kg (a difference of −5.6 kg; 95% confidence interval, −6.0 to −5.1; P<0.001, with last-observation-carried-forward imputation). A total of 63.2% of the patients in the liraglutide group as compared with 27.1% in the placebo group lost at least 5% of their body weight (P<0.001), and 33.1% and 10.6%, respectively, lost more than 10% of their body weight (P<0.001). The most frequently reported adverse events with liraglutide were mild or moderate nausea and diarrhea. Serious events occurred in 6.2% of the patients in the liraglutide group and in 5.0% of the patients in the placebo group. CONCLUSIONSIn this study, 3.0 mg of liraglutide, as an adjunct to diet and exercise, was associated with reduced body weight and improved metabolic control. (Funded by Novo Nordisk; SCALE Obesity and Prediabetes NN8022-1839 ClinicalTrials.gov number, NCT01272219.) a bs tr ac t
Background Studies of weight-control diets that are high in protein or low in glycemic index have reached varied conclusions, probably owing to the fact that the studies had insufficient power. Methods We enrolled overweight adults from eight European countries who had lost at least 8% of their initial body weight with a 3.3-MJ (800-kcal) low-calorie diet. Participants were randomly assigned, in a two-by-two factorial design, to one of five ad libitum diets to prevent weight regain over a 26-week period: a low-protein and low-glycemic-index diet, a low-protein and high-glycemic-index diet, a high-protein and low-glycemic-index diet, a high-protein and high-glycemic-index diet, or a control diet. Results A total of 1209 adults were screened (mean age, 41 years; body-mass index [the weight in kilograms divided by the square of the height in meters], 34), of whom 938 entered the low-calorie-diet phase of the study. A total of 773 participants who completed that phase were randomly assigned to one of the five maintenance diets; 548 completed the intervention (71%). Fewer participants in the high-protein and the low-glycemic-index groups than in the low-protein–high-glycemic-index group dropped out of the study (26.4% and 25.6%, respectively, vs. 37.4%; P = 0.02 and P = 0.01 for the respective comparisons). The mean initial weight loss with the low-calorie diet was 11.0 kg. In the analysis of participants who completed the study, only the low-protein–high-glycemic-index diet was associated with subsequent significant weight regain (1.67 kg; 95% confidence interval [CI], 0.48 to 2.87). In an intention-to-treat analysis, the weight regain was 0.93 kg less (95% CI, 0.31 to 1.55) in the groups assigned to a high-protein diet than in those assigned to a low-protein diet (P = 0.003) and 0.95 kg less (95% CI, 0.33 to 1.57) in the groups assigned to a low-glycemic-index diet than in those assigned to a high-glycemic-index diet (P = 0.003). The analysis involving participants who completed the intervention produced similar results. The groups did not differ significantly with respect to diet-related adverse events. Conclusions In this large European study, a modest increase in protein content and a modest reduction in the glycemic index led to an improvement in study completion and maintenance of weight loss. (Funded by the European Commission; ClinicalTrials.gov number, NCT00390637.)
Objective: Can gestational weight gain in obese women be restricted by 10-h dietary consultations and does this restriction impact the pregnancy-induced changes in glucose metabolism? Design: A randomized controlled trial with or without restriction of gestational weight gain to 6-7 kg by ten 1-h dietary consultations. Subjects: Fifty nondiabetic nonsmoking Caucasian obese pregnant women were randomized into intervention group (n ¼ 23, 2874 years, prepregnant body mass index (BMI) 3574 kg m À2 ) or control group (n ¼ 27, 3075 years, prepregnant BMI 3573 kg m À2 ). Measurements: The weight development was measured at inclusion (15 weeks), at 27 weeks, and 36 weeks of gestation. The dietary intakes were reported in the respective weeks by three 7-day weighed food records and blood samples for analyses of fasting s-insulin, s-leptin, b-glucose, and 2-h b-glucose after an oral glucose tolerance test were collected. Results: The women in the intervention group successfully limited their energy intake, and restricted the gestational weight gain to 6.6 kg vs a gain of 13.3 kg in the control group (P ¼ 0.002, 95% confidence interval (CI): 2.6-10.8 kg). Both s-insulin and s-leptin were reduced by 20% in the intervention group compared to the control group at week 27, mean difference: À16 pmol l À1 (P ¼ 0.04, 95% CI: À32 to À1) for insulin and À23 ng ml À1 (P ¼ 0.004, 95% CI: À39 to À8) for leptin. At 36 weeks of gestation, the s-insulin was further reduced by 23%, À25 pmol l À1 (À47 to À4, P ¼ 0.022) and the fasting b-glucose were reduced by 8% compared with the control group (À0.3 mmol l À1 , À0.6 to À0.0, P ¼ 0.03). Conclusions: Restriction of gestational weight gain in obese women is achievable and reduces the deterioration in the glucose metabolism.
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