JOULE - Metabolic Adaptation to Weight Loss in Response to a Behavioural Lifestyle Program With or Without Semaglutide in Adolescents With Obesity
Trial Parameters
Brief Summary
The Joule MARS study is a single center, randomized, open label clinical trial aiming to explore the metabolic adaptations that occur in response to weight management in adolescents with obesity. Behavioural lifestyle intervention with and without a pharmacological intervention - semaglutide- will be studied. Study participants will be randomized to one of two groups. Group A will follow a behavioral lifestyle program (BLP) alone for 6 months, followed by BLP and treatment with semaglutide for six months. Group B will be enrolled in BLP and semaglutide from baseline to 6 months. The primary research question will assess, in youth aged 12-17 years diagnosed with obesity and enrolled in a weight management program, if the implementation of a BLP together with semaglutide, compared to the implementation of BLP alone for 6 months leads to less adaptive thermogenesis.
Eligibility Criteria
Inclusion Criteria: * Youth aged 12-17 years * Diagnosed with obesity (BMI ≥2 standard deviations above WHO Reference median) * Enrolled in Growing Health Weight Management or Next Step pediatric clinics (ie. have at least one year of the program remaining). Exclusion Criteria: * Any contraindications for MRI (i.e. claustrophobia, implanted metal, metallic injuries recent tattoo or weight \>300lb. Ineligible for imaging visit only. * Use of atypical anti-psychotics. * Use of the following medication classes: (i.e. Beta-blocker medications, Steatogenic medications, Anti-hyperglycemic medications, HIV drugs, Antidepressants, anxiolytic drugs, anti-psychotic drugs, Thyroid drugs, Antiemetic or amphetamine, dextromethorphan and metoclopramide.) * Elevated alanine aminotransferase (ALT) \> 5 x upper range of normal at screening. * Use of glucose lowering or any anti-obesity medication in the previous 3 months. * Known monogenic, syndromic or hypothalamic causes of obesity. * Diagnosis of ty