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

Sex: All

Ages: 21 Years – 99 Years

Healthy volunteers: No

Phase: PHASE4

Enrollment: 29

Sponsor: University of Texas Southwestern Medical Center

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.

Eligibility Criteria

Inclusion Criteria: Idiopathic uric acid nephrolithiasis, with last stone analysis showing that stone has \>90% uric acid in composition Age \>21 years Any gender, race/ethnicity (from weight loss), but weight \60ml/min/1.73 m2 Exclusion Criteria: Bariatric surgery, chronic diarrhea, recurrent UTIs current insulin use use of a thiazolidinedione in past 2 years contraindication to thiazolidinedione use (liver dz, pedal edema, CHF NYHA class III/IV, no contraception) Bladder cancer Use of SGLT2-i, GLP-1 analogs, gemfibrozil, topiramate, rifampin Hba1c \> 8.5%

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04370093). StuddyBuddy aggregates publicly available trial information.