The effect of glucagon-like peptide-1 receptor agonist therapy on body mass index in adolescents with severe obesity: a randomized, placebo-controlled, clinical trial.
The effect of glucagon-like peptide-1 receptor agonist therapy on body mass index in adolescents with severe obesity: a randomized, placebo-controlled, clinical trial.
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DOI：
10.1001/jamapediatrics.2013.1045
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发表时间：
2013-04
期刊：
影响因子：
26.1
通讯作者：
Abuzzahab, M. Jennifer
中科院分区：
文献类型：
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作者：
Kelly, Aaron S.;Rudser, Kyle D.;Nathan, Brandon M.;Fox, Claudia K.;Metzig, Andrea M.;Coombes, Brandon J.;Fitch, Angela K.;Bomberg, Eric M.;Abuzzahab, M. Jennifer
评价艾塞那肽对重度肥胖青少年体重指数（BMI）及心脏代谢危险因素的影响。三个月，随机，双盲，安慰剂对照，多中心临床试验，随后是三个月的开放标签扩展。一个学术医疗中心和一个儿科内分泌门诊诊所。重度肥胖青少年（BMI≥1.2倍第95百分位或≥35 kg/m2） 26例（12-19岁）。所有患者均接受生活方式改变咨询，并平均随机接受艾塞那肽或安慰剂注射，每天两次。主要终点是基线和三个月时测量的BMI平均变化百分比。次要终点包括三个月时BMI、体重、体脂、血压、血红蛋白A1c、空腹血糖、空腹胰岛素和血脂的绝对变化。22名患者完成了试验。与安慰剂相比，艾塞那肽引起的BMI变化百分比降低幅度更大（- 2.70%,95% CI (- 5.02, - 0.37), P = 0.025）。BMI （- 1.13 kg/m2, 95% CI (- 2.03, - 0.24), P = 0.015）和体重（- 3.26 kg, 95% CI (- 5.87, - 0.66), P = 0.017）的绝对变化也有类似的发现。虽然没有达到统计学意义的水平，但可以观察到艾塞那肽降低收缩压。在开放标签扩展期间，最初随机分配到艾塞那肽的患者BMI进一步降低（累计BMI降低4%）。这些结果为胰高血糖素样肽-1受体激动剂治疗青少年重度肥胖的可行性、安全性和有效性提供了初步证据。本研究已在www.clinicaltrials.gov网站（ClinicalTrials.gov识别码：NCT01237197）上注册。
To evaluate the effects of exenatide on body mass index (BMI) and cardiometabolic risk factors in adolescents with severe obesity. Three-month, randomized, double-blind, placebo-controlled, multicenter clinical trial followed by a three-month open label extension. An academic medical center and an outpatient pediatric endocrinology clinic. Twenty-six adolescents (age 12–19 years) with severe obesity (BMI ≥ 1.2 times the 95th percentile or ≥ 35 kg/m2). All patients received lifestyle modification counseling and were equally randomized to exenatide or placebo injection, twice per day. The primary endpoint was the mean percent change in BMI measured at baseline and three-months. Secondary endpoints included absolute change in BMI, body weight, body fat, blood pressure, hemoglobin A1c, fasting glucose, fasting insulin, and lipids at three-months. Twenty-two patients completed the trial. Exenatide elicited a greater reduction in percent change in BMI compared to placebo (−2.70%, 95% CI (−5.02, −0.37), P = 0.025). Similar findings were observed for absolute change in BMI (−1.13 kg/m2, 95% CI (−2.03, −0.24), P = 0.015) and body weight (−3.26 kg, 95% CI (−5.87, −0.66), P = 0.017). Although not reaching the level of statistical significance, reduction in systolic blood pressure was observed with exenatide. During the open label extension, BMI was further reduced in those initially randomized to exenatide (cumulative BMI reduction of 4%). These results provide preliminary evidence supporting the feasibility, safety, and efficacy of glucagon-like peptide-1 receptor agonist therapy for the treatment of severe obesity in adolescents. This study is registered on the www.clinicaltrials.gov website (ClinicalTrials.gov identifier: NCT01237197).
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影响因子：
120.7
作者：
O'Brien, Paul E.;Sawyer, Susan M.;Dixon, John B.
通讯作者：
Dixon, John B.
影响因子：
5.1
作者：
Johnston, Craig A.;Tyler, Chermaine;Foreyt, John P.
通讯作者：
Foreyt, John P.
影响因子：
6.9
作者：
Norris, Anne L.;Steinberger, Julia;Steffen, Lyn M.;Metzig, Andrea M.;Schwarzenberg, Sarah Jane;Kelly, Aaron S.
通讯作者：
Kelly, Aaron S.
二甲双胍的延长释放治疗青少年肥胖症：一项为期48周的随机，双盲，安慰剂对照试验，随访48周。
影响因子：
--
作者：
Wilson, Darrell M.;Abrams, Stephanie H.;Aye, Tandy;Lee, Phillip D. K.;Lenders, Carine;Lustig, Robert H.;Osganian, Stavroula V.;Feldman, Henry A.
通讯作者：
Feldman, Henry A.
影响因子：
3.1
作者：
Skelton JA;Cook SR;Auinger P;Klein JD;Barlow SE
通讯作者：
Barlow SE