| Effects of exenatide combined with lifestyle modification in patients with type 2 diabetes. | |
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MedLine Citation:
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PMID: 20399326 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: To determine the effect of a lifestyle modification program plus exenatide versus lifestyle modification program plus placebo on weight loss in overweight or obese participants with type 2 diabetes treated with metformin and/or sulfonylurea. METHODS: In this 24-week, multicenter, randomized, double-blind, placebo-controlled study, 194 patients participated in a lifestyle modification program, consisting of goals of 600 kcal/day deficit and physical activity of at least 2.5 hours/week. Participants were randomized to 5 microg exenatide twice daily injection + lifestyle modification program (n = 96) or placebo + lifestyle modification program (n = 98), and after 4 weeks increased their exenatide dose to 10 microg twice daily or volume equivalent of placebo. RESULTS: Baseline characteristics: (mean +/- standard deviation) age, 54.8 +/- 9.5 years; weight, 95.5 +/- 16.0 kg; hemoglobin A(1c), 7.6 +/- 0.8%. At 24 weeks (least squares mean +/- standard error), treatments showed similar decreases in caloric intake (-378 +/- 58 vs -295 +/- 58 kcal/day, exenatide + lifestyle modification program vs placebo + lifestyle modification program, P = .27) and increases in exercise-derived energy expenditure. Exenatide + lifestyle modification program showed greater change in weight (-6.16 +/- 0.54 kg vs -3.97 +/- 0.52 kg, P = .003), hemoglobin A(1c) (-1.21 +/- 0.09% vs -0.73 +/- 0.09%, P <.0001), systolic (-9.44 +/- 1.40 vs -1.97 +/- 1.40 mm Hg, P <.001) and diastolic blood pressure (-2.22 +/- 1.00 vs 0.47 +/- 0.99 mm Hg, P = .04). Nausea was reported more for exenatide + lifestyle modification program than placebo + lifestyle modification program (44.8% vs 19.4%, respectively, P <.001), with no difference in withdrawal rates due to adverse events (4.2% vs 5.1%, respectively, P = 1.0) or rates of hypoglycemia. CONCLUSIONS: When combined with lifestyle modification, exenatide treatment led to significant weight loss, improved glycemic control, and decreased blood pressure compared with lifestyle modification alone in overweight or obese participants with type 2 diabetes on metformin and/or sulfonylurea treatment. |
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Authors:
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Caroline M Apovian; Richard M Bergenstal; Robert M Cuddihy; Yongming Qu; Sheila Lenox; Michelle S Lewis; Leonard C Glass |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The American journal of medicine Volume: 123 ISSN: 1555-7162 ISO Abbreviation: Am. J. Med. Publication Date: 2010 May |
Date Detail:
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Created Date: 2010-04-19 Completed Date: 2010-04-29 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0267200 Medline TA: Am J Med Country: United States |
Other Details:
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Languages: eng Pagination: 468.e9-17 Citation Subset: AIM; IM |
Copyright Information:
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Copyright 2010 Elsevier Inc. All rights reserved. |
Affiliation:
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Section of Endocrinology, Diabetes and Nutrition, Department of Medicine, Boston University School of Medicine, Boston, MA, USA. caroline.apovian@bmc.org |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Aged Blood Glucose / analysis Blood Pressure Body Weight Diabetes Mellitus, Type 2 / therapy* Double-Blind Method Female Glucagon-Like Peptide 1 / physiology Humans Hypoglycemic Agents / therapeutic use* Life Style* Male Middle Aged Peptides / therapeutic use* Venoms / therapeutic use* |
| Chemical | |
Reg. No./Substance:
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0/Blood Glucose; 0/Hypoglycemic Agents; 0/Peptides; 0/Venoms; 141732-76-5/exenatide; 89750-14-1/Glucagon-Like Peptide 1 |
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