Health Trials

About this trial

The goal of this clinical trial is to compare bone health markers over 24 months in participants 12 - 21 years of age with obesity who are starting the glucagon-like peptide-1 receptor agonists (GLP-1RAs) as compared to those with similar weight followed by lifestyle management.

Participants will:

* Take GLP-1RA as prescribed or continue to work on lifestyle management for weight loss * Take provided calcium and vitamin D supplements * Attend 6 study visits over 24 months with two at the beginning and then every 6 months that include:

* History and Physical Exams * Lab Work * Imaging studies * Questionnaires * 24-hour dietary recalls

Eligibility criteria

Qualifiers

• Adolescents and young adults with obesity 12-21 years old starting GLP-1 RA therapy (except for dulaglutide or exenatide) or followed with 'usual' care.

Diagnosis of obesity (BMI ≥ 95th percentile for age and sex). The FDA has approved the use of GLP-1 RAs (liraglutide and semaglutide) for adolescents ≥ 12 years old with BMI ≥ 95th percentile for age and sex, and tirzepatide for adults with obesity. Those in the GLP-1 RA arm must have demonstrated efforts at weight loss with 'usual' care, and consistent compliance with appointments and recommendations.

Participants must demonstrate sufficient maturity, psychological stability and cognitive capacity to recognize the significance of being on medical therapy and implement required behavioral changes

Patients taking orlistat as a precursor to GLP-1 RA therapy due to insurance requirements may be included given minimal effects on weight.

Disqualifiers

• Current or previous history of pregnancy and breast feeding.

Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 if in the GLP-1 RA group.

> 5 kg weight loss over 3 months given the known impact of significant weight loss on bone density.

Use of dulaglutide and exenatide (of the GLP-1 RAs) given minimal weight loss with these drugs.

Trial design

Treatments tested in this trial

  • GLP-1 receptor agonist
  • Lifestyle intervention

Treatment groups

120 Participants
are divided into 2 treatment groups

Locations

1
University of Virginia Medical Center22903, CharlottesvilleVirginia, United States

Sponsors and collaborators

University of Virginia

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov