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All the authors were involved in the design or conduct of the study and the preparation of the manuscript, including the decision to submit it for publication, and all attest to the accuracy and completeness of data and the data analyses. Media in This Article QUICK TAKE VIDEO SUMMARY The SCALE Trial Figure 1 Liraglutide and Body Weight. The project staff of the National Heart, Lung, and Blood Institute also participated in the development of the protocol, monitoring of progress, interpretation of results, and critical review of the manuscript. Abstract Background Obesity is a chronic disease with serious health consequences, but weight loss is difficult to maintain through lifestyle intervention alone. Participants Our goal was to recruit 800 overweight and obese subjects (400 at each site), of whom about 40% would be men. The diets improved lipid-related risk factors and fasting insulin levels. Figure 2 Mean Changes in Body Weight and Waist Circumference at Various Time Points. Abstract Background The possible advantage for weight loss of a diet that emphasizes protein, fat, or carbohydrates has not been established, and there are few studies that extend beyond 1 year. (ClinicalTrials. Media in This Article Poll Results Contributors Figure 1 Mean Change in Body Weight and Waist Circumference from Baseline to 2 Years According to Dietary Macronutrient Content. Methods Study Overview We conducted the study from June 1, 2011, through March 18, 2013, at 191 sites in 27 countries in Europe, North America, South America, Asia, Africa, and Australia. Conclusions Reduced-calorie diets result in clinically meaningful weight loss regardless of which macronutrients they emphasize.
Thus, we recognized the need for a large trial that would be designed to overcome the limitations of previous trials and that would compare the effects of three principal dietary macronutrients. gov number, NCT00072995. ) Full Text of Discussion. 0 mg, injected subcutaneously. The primary outcome was the change in body weight after 2 years in two-by-two factorial comparisons of low fat versus high fat and average protein versus high protein and in the comparison of highest and lowest carbohydrate content. The participants were offered group and individual instructional sessions for 2 years. The diets consisted of similar foods and met guidelines for cardiovascular health. Liraglutide, a glucagon-like peptide-1 analogue, has been shown to have potential benefit for weight management at a once-daily dose of 3. Details of the eligibility and exclusion criteria are provided in the Supplementary Appendix. The sponsor, Novo Nordisk, planned and performed the statistical analyses, provided editorial and writing assistance, and provided the trial drugs. Figure 2 Liraglutide and Glucose Levels during Oral Glucose-Tolerance Test and Glycemic Status. The crucial question is whether overweight people have a better response in the long term to diets that emphasize a specific macronutrient composition. 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. Key exclusion criteria were type 1 or 2 diabetes, the use of medications that cause clinically significant weight gain or loss, previous bariatric surgery, a history of pancreatitis, a history of major depressive or other severe psychiatric disorders, and a family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma. Study Design and Treatments Randomization was performed with the use of a telephone or Web-based system provided by the sponsor.
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