Advancing ADPKD Treatment With GLP-1RA: A Study of Glucagon-Like Peptide-1 Receptor Agonists' Efficacy, Safety, and Mechanism
University of Colorado, Denver
Summary
The proposed clinical trial aims to assess if a year of treatment with a glucagon-like peptide 1 receptor agonist, a medication approved for weight management that also improves the body's response to glucose and insulin, can slow kidney growth in adults with autosomal dominant polycystic kidney disease who are overweight or obese. The study will also evaluate changes in abdominal fat and kidney metabolism using cutting-edge images techniques. Blood and urine samples will provide further insight into biological changes that may be linked to the benefits of the intervention, while ensuring careful monitoring of safety and tolerability.
Description
Autosomal dominant polycystic kidney disease (ADPKD) is a common inherited disorder that leads to kidney failure. The only approved treatment to decelerate kidney disease progression in patients with ADPKD is tolvaptan, but its usage is limited due to frequent side effects affecting adherence. Thus, alternative interventions that may slow ADPKD progression hold considerable clinical importance. In line with the general population, body-mass index and insulin resistance have been increasing in patients with ADPKD. The investigators have shown that visceral adiposity associates strongly with acc…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 18-65 years of age * ADPKD diagnosis based on the modified Pei-Ravine criteria * Body-mass index of ≥27 kg/m\^2 * Estimated glomerular filtration rate ≥ 30 mL/min/1.73m\^2 * Mayo Classification of C, D, or E, calculated from a previous kidney ultrasound or MRI performed within the last 12 months * Not currently participating in or planning to participate in any formal weight loss or physical activity program, or another interventional study * Ability to provide informed consent Exclusion Criteria: * Diabetes mellitus * Tolvaptan usage or plans to initiate tolvaptan * H…
Interventions
- DrugTirzepatide
Titrated to dose of 5 mg once weekly subcutaneous
- OtherPlacebo
Titrated to dose of 5 mg once weekly subcutaneous
Location
- University of Colorado - Anschutz Medical CampusAurora, Colorado