RECRUITING

Glucagon-Like Peptide-1 Receptor Agonist in ADPKD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Advancing ADPKD Treatment With GLP-1RA: A Study of Glucagon-Like Peptide-1 Receptor Agonists' Efficacy, Safety, and Mechanism

Quick Facts

Study Start:2025-03-06
Study Completion:2029-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06582875

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-65 years of age
  2. * ADPKD diagnosis based on the modified Pei-Ravine criteria
  3. * Body-mass index of ≥27 kg/m\^2
  4. * Estimated glomerular filtration rate ≥ 30 mL/min/1.73m\^2
  5. * Mayo Classification of C, D, or E, calculated from a previous kidney ultrasound or MRI performed within the last 12 months
  6. * Not currently participating in or planning to participate in any formal weight loss or physical activity program, or another interventional study
  7. * Ability to provide informed consent
  1. * Diabetes mellitus
  2. * Tolvaptan usage or plans to initiate tolvaptan
  3. * History of hospitalization or major surgery within the last 3 months
  4. * Uncontrolled hypertension (systolic blood pressure \> 160 or diastolic blood pressure \>100 mm Hg)
  5. * Pregnancy, lactation, or unwillingness to use adequate birth control
  6. * Regular use of prescription or over-the-counter medications that may affect weight, appetite, food intake, or energy metabolism
  7. * History of clinically diagnosed eating disorder including: anorexia nervosa, bulimia, binge eating disorder
  8. * Weight change of \>5% in the past 3 months for any reason except post-partum weight loss
  9. * Inability to cooperate with or clinical contraindication for MRI including: severe claustrophobia, implants, devices, or non-removable body piercings
  10. * Presence or personal history of malignant neoplasm within 5 years prior to the day of screening
  11. * Personal or family history of medullary thyroid carcinoma, thyroid nodule, or multiple endocrine neoplasia type 2
  12. * Prior history of pancreatitis
  13. * Weight ≥450 lb

Contacts and Locations

Study Contact

Kristen Nowak, PhD, MPH
CONTACT
3037244842
Kristen.Nowak@cuanschutz.edu
Emily Andrews
CONTACT
303-724-7790
Emily.S.Andrews@cuanschutz.edu

Study Locations (Sites)

University of Colorado - Anschutz Medical Campus
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-06
Study Completion Date2029-06-30

Study Record Updates

Study Start Date2025-03-06
Study Completion Date2029-06-30

Terms related to this study

Keywords Provided by Researchers

  • GLP1RA

Additional Relevant MeSH Terms

  • Autosomal Dominant Polycystic Kidney
  • Obesity