| Trial ID: | L2717 |
| Source ID: | NCT04621929
|
| Associated Drug: |
Phentermine / Topiramate Oral Product
|
| Title: |
Obesity and Uric Acid Stones Study
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Obesity|Uric Acid Stones|Type 2 Diabetes Mellitus in Obese|Pre-Diabetes
|
| Interventions: |
DRUG: Phentermine / Topiramate Oral Product|COMBINATION_PRODUCT: Citrate Salts, Allopurinol, Diet
|
| Outcome Measures: |
Primary: Kidney stone growth (mm2) as determined by non-contrast CT scan, Existing kidney stone growth, 18 months|New kidney stone formation (mm2) as determined by non-contrast CT scan, Formation of a new kidney stone, 18 months | Secondary: Change in weight, Expressed as total percent body weight loss (total weight loss in pounds/starting weight in pounds), 18 months|Change in urinary pH parameters, Absolute change in urine pH (end of study compared to baseline), 18 months|Change in hemoglobin A1c, Percent change in A1c (end of study compared to baseline), 18 months|Change in urinary citrate parameters, Percent change in urinary citrate, 18 months|Change in urinary calcium parameters, Percent change in urinary calcium, 18 months|Change in urinary uric acid parameters, Percent change in urinary uric acid, 18 months
|
| Sponsor/Collaborators: |
Sponsor: University of Florida | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
22
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-03-31
|
| Completion Date: |
2024-11-14
|
| Results First Posted: |
|
| Last Update Posted: |
2025-03-30
|
| Locations: |
University of Florida, Gainesville, Florida, 32610, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04621929
|
