Investigating the effects of Pioglitazone and weight loss on uric acid kidney stones
Pathogenesis of Uric Acid Nephrolithiasis: Role of Pioglitazone/Weight Loss
This study is testing whether the diabetes drug Pioglitazone, weight loss, or a combination of both can help people with uric acid kidney stones by looking at changes in their urine and overall health over 24 weeks.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 21 Years to 99 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT04370093 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the impact of Pioglitazone, weight loss, and their combination on urine chemistry in patients with idiopathic uric acid nephrolithiasis. Participants will be randomized into three groups: one receiving Pioglitazone, another focusing on weight loss, and a third combining both interventions. The study will assess changes in urine acid-base parameters, fat distribution, insulin sensitivity, and serum adiponectin over a 24-week period while controlling dietary factors. The primary endpoint is the change in urine pH, with additional evaluations of serum and urine markers.
Who should consider this trial
Good fit: Ideal candidates are overweight or obese adults over 21 years old with a history of uric acid nephrolithiasis.
Not a fit: Patients with a history of bariatric surgery, chronic diarrhea, or those currently using insulin or certain other medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new strategies for preventing recurrent uric acid kidney stones in overweight and obese patients.
How similar studies have performed: Previous studies have indicated metabolic interventions can influence urine chemistry, but this specific combination approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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 \<165 Kg (to fit into MR instrument); eGFR\>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%
Where this trial is running
Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Khashayar Sakhaee, MD — Utsw
- Study coordinator: Khashayar Sakhaee, MD
- Email: Khashayar.Sakhaee@UTSouthwestern.edu
- Phone: 214-648-0324
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.