💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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 type 1 or 2 diabetes mellitus.
* Prior bariatric surgery or liver transplantation.
* Alcohol intake exceeding 3 drinks per week or reported cannabis use.
* Recent history of cigarette smoking (previous 3 months) - ineligible for imaging only.
* History or family history of multiple endocrine neoplasia 2 or medullary thyroid cancer.
* History of pancreatitis.
* Presence of untreated endocrine disorder.
* History of an eating disorder and / or history of suicidal ideation
* History of a cardiac condition that precludes exercise testing or unable to have exercise testing done in the GHWM pediatric clinic, inability to use a cycle ergometer.
Participant who does not have a peak power value obtained in the GHWM pediatric clinic
Female who is pregnant, breast-feeding or intends to become pregnant.
Female who refuses to use a means of contraception if sexually active.
Participation in any interventional clinical study within 90 days before screening.
💊
What it tests
- Semaglutide Pen Injector
- Behavioural Lifestyle Program (BLP)
McMaster University
Hamilton, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
HealthTeky