Double-blinded, 6 Months Study With Bydureon® or Placebo in Adolescents With Obesity to Explore Changes in BMI
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

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.
    


Intervention name(s): Exenatide; Placebo
Intervention type(s): Drug; Behavioral
Intervention description(s): Bydureon (Exenatide once weekly) injections s.c.; Placebo once weekly injections sc
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment