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

Summary: Background: 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. Objective: To investigate the effect of exenatide extended release on body mass index (BMI)‐SDS a...

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Published in:Pediatric Obesity Vol. 15; no. 7; pp. 1 - 12
Main Authors: Weghuber, D., Forslund, A., Ahlström, H., Alderborn, A., Bergström, K., Brunner, S., Cadamuro, J., Ciba, I., Dahlbom, M., Heu, V., Hofmann, J., Kristinsson, H., Kullberg, J., Ladinger, A., Lagler, F. B., Lidström, M., Manell, H., Meirik, M., Mörwald, K., Roomp, K.
Format: research tables/charts randomized controlled trial Journal Article
Published: Wiley-Blackwell Jul2020
Online Access:View this record in EBSCOhost
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        20476302
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      jtl: Pediatric Obesity
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    pubinfo:
      dt: Jul2020
      vid: 15
      iid: 7
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      pub: Wiley-Blackwell
      place: Malden, Massachusetts
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        143678192
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        143678192
        10.1111/ijpo.12624
        143678192
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        atl: A 6‐month randomized, double‐blind, placebo‐controlled trial of weekly exenatide in adolescents with obesity.
      aug:
        au:
          Weghuber, D.
          Forslund, A.
          Ahlström, H.
          Alderborn, A.
          Bergström, K.
          Brunner, S.
          Cadamuro, J.
          Ciba, I.
          Dahlbom, M.
          Heu, V.
          Hofmann, J.
          Kristinsson, H.
          Kullberg, J.
          Ladinger, A.
          Lagler, F. B.
          Lidström, M.
          Manell, H.
          Meirik, M.
          Mörwald, K.
          Roomp, K.
        affil: Department of Paediatrics, Paracelsus Medical University, Salzburg, Austria
      sug:
        subj:
          Pediatric Obesity Drug Therapy
          Body Mass Index Evaluation
          Exenatide Administration and Dosage
          Treatment Outcomes
          Blood Glucose Metabolism
          Cardiovascular Risk Factors Prevention and Control
          Metabolic Diseases Prevention and Control
          Fatty Liver Prevention and Control
          Human
          Child
          Adolescence
          Randomized Controlled Trials
          Double-Blind Studies
          Male
          Female
          World Health Organization
          Injections, Subcutaneous
          Glucose Tolerance Test
          Waist Circumference Evaluation
          Body Weight Evaluation
          Adipose Tissue Analysis
          Cholesterol Analysis
          Drug Tolerance
          Adverse Drug Event
          Child: 6-12 years
          Adolescent: 13-18 years
          Male
          Female
      ab: Summary: Background: 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. Objective: 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. Methods: 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. Results: 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. Conclusions: 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.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        randomized controlled trial
        Journal Article
      ougenre: Article
    language: English
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