The investigator proposes an 18 month, feasibility pilot study, randomizing obese and diabetic individuals with pure uric acid nephrolithiasis (UAN) or mixed calcium oxalate (CO) UAN to either phentermine/topiramate or a pragmatic control group who will remain on their standard medication regimen (citrate salts, allopurinol, diet, etc.).
Mounting evidence indicates that obesity, diabetes mellitus, and kidney stones are inter-connected diseases, particularly uric acid nephrolithiasis (UAN) with or without components of calcium oxalate (CO). Obese or overweight diabetics have a six-fold increased risk to develop UAN/COUAN due to the inability to properly add buffer (ammonium) to urine. Of the FDA approved drugs in the weight loss market, the combination medication phentermine/ topiramate is the most effective and has a unique side effect of alkalinizing the urine (making it less acidic). The hypothesize of this project is that treatment of obese, diabetic patients with phentermine/topiramate will reduce the incidence of UAN/COUAN by 1) direct urinary alkalinization and 2) weight loss. Weight loss will indirectly improve urinary buffering ability through improvement in insulin sensitivity and will decrease renal oxidative stress. The investigative team proposes an 18 month, feasibility pilot study, randomizing 30 obese and diabetic individuals with UAN/COUAN to either phentermine/topiramate (n=20) or a pragmatic control group (n=10) who would remain on standard medication regimen (citrate salts, allopurinol, diet, etc).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
All participants in the experimental group will receive oral generic tablet phentermine (18.75 or 37.5 mg dose) and topiramate (daily 100 mg or 150 mg dose)
Control participants will complete initial visit requirements and study enrollment and will be maintained on their current therapy.
University of Florida
Gainesville, Florida, United States
Kidney Stone Size (mm^3) Determined by Non-contrast CAT Scan
Stone perimeter within each cut of CT image was outlined using semiautomated volume tool (region of interest pen tool, CT software "Visage Imaging") and tallied to calculate stone volume (mm\^3) for each individual stone and recorded from right and left kidney from all study participants at baseline CT and at end of study CT (18 months)
Time frame: Baseline, 18 months
Weight (kg)
total weight (baseline and end of study)
Time frame: Baseline, 18 months
Urinary pH Parameters
urine pH (baseline and end of study). The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic.
Time frame: Baseline, 18 months
%Hemoglobin A1c
%A1c (baseline and end of study)
Time frame: Baseline, 18 months
Urinary Citrate Parameters
urinary citrate (baseline and end of study)
Time frame: Baseline, 18 months
Urinary Calcium Parameters
urinary calcium (baseline and end of study)
Time frame: Baseline, 18 months
Urinary Uric Acid Supersaturation (SS)
Urinary uric acid SS (before and end of study). Urinary Uric Acid Supersaturation (SS) is not measured in a specific unit, as it is a ratio. Result below 1: The urine is undersaturated, meaning that crystals are more likely to dissolve than form. Result equal to 1: The urine is in equilibrium with uric acid, so crystals will not grow or shrink. Result above 1: The urine is supersaturated, and the risk for crystals to form and grow is increased. A higher value indicates a greater risk.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline, 18 months