Study of the Biological and Physical Manifestations of Spontaneous Uric Acid Kidney Stone Disease (IUAN)
This study has two aims:
Aim 1: To determine the presence of accumulation of fat within cells and the functional consequences of this in the kidney by correlating kidney fat content with urine test results.
Aim 2: The investigators will evaluate the effect of thiazolidinedione (pioglitazone) on excess fatty acid accumulation in kidney tissue and its correlation with uric acid stone formation in subjects with uric acid stones.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
|Official Title:||Pathophysiology of Uric Acid Nephrolithiasis|
- Reversal of renal lipotoxicity will occur with pioglitazone. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||April 2019 (Final data collection date for primary outcome measure)|
30 mg orally daily for 6 months
Other Name: Thiazolidinedione
|Placebo Comparator: Placebo||
Placebo taken orally once a day for 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904046
|Contact: Ann Heard-Sakhaee, RN||214-648-4893||Ann.Heard-Sakhaee@UTSouthwestern.edu|
|Contact: Marsha Roberts, RN||214-648-0399||marsha.roberts@UTSouthwestern.edu|
|United States, Texas|
|UT Southwestern Medical Center - Center for Mineral Metabolism||Recruiting|
|Dallas, Texas, United States, 75390-8885|