NCT02794402

Double-blinded, 6 Months Study With Bydureon® or Placebo in Adolescents With Obesity to Explore Changes in BMI

A Parallel, Double-blinded, Randomized, 6 Months, Two Arms Study With Lifestyle Intervention and Bydureon® or Lifestyle Intervention and Placebo in Adolescents With Obesity to Explore Differences With Regard to Change in BMI SDS

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Combat-JUDO (Combating Juvenile Diabetes and Obesity through normalization of beta-cell function) is part of a collaborative project funded by the Seventh Framework Programme of the European Commission aiming to develop innovative therapeutic strategies by increasing pharmacology-based alternatives targeting insulin hypersecretion for the treatment of young obese individuals. The prevalence of childhood obesity is ranging between 5-25% in Europe. The reason behind these alarming figures is mostly a changing environment with a more sedative lifestyle and supply of excess food. However, specific gene mutations have also been linked to obesity and new genes are continuously being discovered. There are very few effective means of intervention in children with obesity available today. Obesity is closely associated with a number of related metabolic diseases and some children with obesity develop the metabolic syndrome at an early stage in life. Individuals with obesity have an increased risk of developing type 2 diabetes mellitus (T2DM) and with the current increase in childhood obesity, some children will develop T2DM already in their adolescent years with huge impact on their long-term health and life expectancy. Lifestyle modification interventions, including behavioural treatment, diet modification and physical activity, are cornerstones of primary and secondary prevention/treatment of pediatric obesity today. Exenatide is a GLP-1 (glucagon-like peptide-1) receptor agonist approved for use in adults with T2DM to improve glycemic control. A pilot study with exenatide treatment in non-diabetic children and adolescents with severe obesity showed a reduced BMI of approximately 5% and improved markers of insulin resistance and β-cell function were observed. The Combat-JUDO study is a parallel, double-blind, randomized study comparing lifestyle intervention + exenatide 2 mg vs lifestyle and intervention + placebo in adolescents with obesity. The lifestyle intervention includes regular nutritional and psychological support at 4 occasions during the study as well as physical activity on a weekly basis. Exenatide/placebo is given as a subcutaneous injection once weekly for 24 weeks. The primary objective of the study is to compare the change in BMI-SDS (according to WHO) from baseline to the 6 months visit between the two treatment arms. The study includes males and females of age 10-18 years and 5 months with BMI SDS \>2.0 or age-adapted BMI \>30 kg/m2.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Exenatide	Bydureon (Exenatide once weekly) injections s.c.
BEHAVIORAL	Placebo	Placebo once weekly injections sc

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-09-01
• Completion: 2016-11-01
• First posted: 2016-06-09
• Last updated: 2022-05-18

Locations

2 sites across 2 countries: Austria, Sweden