Clinical trial

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

Name

STU-2019-0907

Description

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.

Trial arms

Trial start

2019-10-17

Estimated PCD

2024-06-01

Trial end

2024-07-01

Status

Recruiting

Phase

Early phase I

Treatment

Pioglitazone 45 mg

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

Arms:

Pioglitazone Drug (including Placebo)

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.

Arms:

Weight Loss, Behavioral

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.

Arms:

Pioglitazone + Weight Loss

Size

Primary endpoint

Urine pH

24 weeks

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 \<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%

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 54, 'type': 'ESTIMATED'}}

Updated at

2024-03-01

1 organization

1 product

2 indications

Organization

University of Texas Southwestern Medical Center

Product

Pioglitazone

Indication

Kidney stones

Indication

Uric Acid