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A 6-month randomized, double-blind, placebo-controlled trial of weekly exenatide in adolescents with obesity. 2020

D Weghuber, and A Forslund, and H Ahlström, and A Alderborn, and K Bergström, and S Brunner, and J Cadamuro, and I Ciba, and M Dahlbom, and V Heu, and J Hofmann, and H Kristinsson, and J Kullberg, and A Ladinger, and F B Lagler, and M Lidström, and H Manell, and M Meirik, and K Mörwald, and K Roomp, and R Schneider, and H Vilén, and K Widhalm, and F Zsoldos, and P Bergsten
Department of Paediatrics, Paracelsus Medical University, Salzburg, Austria.

Pharmacological treatment options for adolescents with obesity are very limited. Glucagon-like-peptide-1 (GLP-1) receptor agonist could be a treatment option for adolescent obesity. To investigate the effect of exenatide extended release on body mass index (BMI)-SDS as primary outcome, and glucose metabolism, cardiometabolic risk factors, liver steatosis, and other BMI metrics as secondary outcomes, and its safety and tolerability in adolescents with obesity. Six-month, randomized, double-blinded, parallel, placebo-controlled clinical trial in patients (n = 44, 10-18 years, females n = 22) with BMI-SDS > 2.0 or age-adapted-BMI > 30 kg/m2 according to WHO were included. Patients received lifestyle intervention and were randomized to exenatide extended release 2 mg (n = 22) or placebo (n = 22) subcutaneous injections given once weekly. Oral glucose tolerance tests (OGTT) were conducted at the beginning and end of the intervention. Exenatide reduced (P < .05) BMI-SDS (-0.09; -0.18, 0.00), % BMI 95th percentile (-2.9%; -5.4, -0.3), weight (-3 kg; -5.8, -0.1), waist circumference (-3.2 cm; -5.8, -0.7), subcutaneous adipose tissue (-552 cm3 ; -989, -114), 2-hour-glucose during OGTT (-15.3 mg/dL; -27.5, -3.1), total cholesterol (11.6 mg/dL; -21.7, -1.5), and BMI (-0.83 kg/m2 ; -1.68, 0.01) without significant change in liver fat content (-1.36; -3.12, 0.4; P = .06) in comparison to placebo. Safety and tolerability profiles were comparable to placebo with the exception of mild adverse events being more frequent in exenatide-treated patients. Treatment of adolescents with severe obesity with extended-release exenatide is generally well tolerated and leads to a modest reduction in BMI metrics and improvement in glucose tolerance and cholesterol. The study indicates that the treatment provides additional beneficial effects beyond BMI reduction for the patient group.

UI MeSH Term Description Entries
D008297 Male Males
D002648 Child A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL. Children
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260 Female Females
D005951 Glucose Tolerance Test A test to determine the ability of an individual to maintain HOMEOSTASIS of BLOOD GLUCOSE. It includes measuring blood glucose levels in a fasting state, and at prescribed intervals before and after oral glucose intake (75 or 100 g) or intravenous infusion (0.5 g/kg). Intravenous Glucose Tolerance,Intravenous Glucose Tolerance Test,OGTT,Oral Glucose Tolerance,Oral Glucose Tolerance Test,Glucose Tolerance Tests,Glucose Tolerance, Oral
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000077270 Exenatide A synthetic form of exendin-4, a 39-amino acid peptide isolated from the venom of the GILA MONSTER lizard (Heloderma suspectum). Exenatide increases CYCLIC AMP levels in pancreatic acinar cells and acts as a GLUCAGON-LIKE PEPTIDE-1 RECEPTOR (GLP-1) agonist and incretin mimetic, enhancing insulin secretion in response to increased glucose levels; it also suppresses inappropriate glucagon secretion and slows gastric emptying. It is used as an anti-diabetic and anti-obesity agent. AC 2993,AC 2993 LAR,Bydureon,Byetta,Ex4 Peptide,Exendin 4,Exendin-4,ITCA 650,Peptide, Ex4
D000293 Adolescent A person 13 to 18 years of age. Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths
D015992 Body Mass Index An indicator of body density as determined by the relationship of BODY WEIGHT to BODY HEIGHT. BMI Quetelet Index,Quetelet's Index,Index, Body Mass,Index, Quetelet,Quetelets Index
D019440 Anti-Obesity Agents Agents that increase energy expenditure and weight loss by neural and metabolic regulation. Anti-Obesity Agent,Anti-Obesity Drug,Antiobesity Agent,Antiobesity Drug,Weight-Loss Agents,Weight-Loss Drug,Anti-Obesity Drugs,Antiobesity Agents,Antiobesity Drugs,Weight-Loss Drugs,Agent, Anti-Obesity,Agent, Antiobesity,Agents, Anti-Obesity,Agents, Antiobesity,Agents, Weight-Loss,Anti Obesity Agent,Anti Obesity Agents,Anti Obesity Drug,Anti Obesity Drugs,Drug, Anti-Obesity,Drug, Antiobesity,Drug, Weight-Loss,Drugs, Anti-Obesity,Drugs, Antiobesity,Drugs, Weight-Loss,Weight Loss Agents,Weight Loss Drug,Weight Loss Drugs

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