Double-blinded, 6 Months Study With Bydureon® or Placebo in Adolescents With Obesity to Explore Changes in BMI
Status:
Unknown status
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
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.