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COMPLETED
NCT04370093
PHASE4

Pathogenesis of Uric Acid Nephrolithiasis: Role of Pioglitazone/Weight Loss

Sponsor: University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

Summary

The investigators will randomize overweight and obese iuan patients to Pio (45 mg/day, highest approved dose or placebo), WL (10% of body weight, following the established program used in the Diabetes Prevention Program), or Pio+WL. Participants will be evaluated at baseline and after 24 weeks of intervention while on a fixed metabolic diet to exclude the confounding effects of diet and perspiration. The primary endpoint will be change in upH, and multiple additional endpoints (serum, urine, imaging) will be assessed.

Key Details

Gender

All

Age Range

21 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

29

Start Date

2019-10-17

Completion Date

2025-05-28

Last Updated

2026-08-31

Healthy Volunteers

No

Interventions

DRUG

Pioglitazone 45 mg

45 mg/day- one pioglitazone tablet once daily throughout the 24 weeks of the study

BEHAVIORAL

Weight Loss

Weight loss following the Group Lifestyle Balance Program based on the Diabetes Prevention Program that utilizes cognitive behavioral strategies (goal setting, problem solving, self-monitoring, stimulus control),and provides written education materials to support health and nutrition behavior changes for weight management and disease prevention.

OTHER

Pioglitazone + Weight Loss

Pioglitazone + Weight loss following the Group Lifestyle Balance Program based on the Diabetes Prevention Program that utilizes cognitive behavioral strategies (goal setting, problem solving, self-monitoring, stimulus control),and provides written education materials to support health and nutrition behavior changes for weight management and disease prevention.

Locations (1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States