NCT06496542

Renal Oxygen Consumption, Insulin Sensitivity, and Daily Caloric Restriction in ADPKD

Renal Oxygen Consumption, Insulin Sensitivity, and Daily Caloric Restriction in Autosomal Dominant Polycystic Kidney Disease (EXPLORE Study)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The proposed research is a pilot study assessing kidney oxidative metabolism and insulin sensitivity after a 2-year weight loss intervention in those with autosomal dominant polycystic kidney disease who are overweight or obese.

Detailed description

Autosomal dominant polycystic kidney disease (ADPKD) is the most commonly inherited progressive kidney disease. Overweight and obese phenotypes have been associated with disease progression in early-stage ADPKD. Daily caloric restriction (DCR, 34% restriction per day from baseline weight maintenance requirements) may aid in weight loss and ultimately slow ADPKD disease progression. Weight loss via DCR may cause alterations in kidney oxidative metabolism and insulin sensitivity that can affect ADPKD disease progression. This study aims to assess kidney oxidative metabolism via 11C-acetate PET scan protocol and insulin sensitivity via hyperinsulinemic-euglycemic clamp by leveraging an ongoing R01-funded trial (NCT04907799) in DCR (n=10) vs. control (n=10) groups at baseline (BSL) and 2 years. The study will utilize the clinical outcome measures performed in the parent trial to address the subsequent novel aims: Aim 1: Compare kidney oxidative metabolism and insulin sensitivity at BSL and 2 years in adults with ADPKD. Aim 2: Define the relations among changes in kidney oxidative metabolism, insulin sensitivity, total kidney volume, and weight over 2 years. Currently, it is unknown if weight loss via DCR modifies renal energy expenditure and substrate utilization.

Conditions

• Autosomal Dominant Polycystic Kidney

Interventions

Type	Name	Description
BEHAVIORAL	Daily caloric restriction	Weight loss based on daily caloric restriction and increased physical activity
OTHER	Standard advice control	Initial nutrition consultation without subsequent counseling

Timeline

• Start date: 2023-01-13
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-07-11
• Last updated: 2025-08-21

Locations

1 site across 1 country: United States