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Drug

Weight-Loss Drugs + Supplements for Uric Acid Kidney Stones

Phase 3
Recruiting
Led By Benjamin Canales, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have type 2 diabetes mellitus or pre-diabetes, defined as previously diagnosed by laboratory testing (hemoglobin A1c, fasting plasma glucose, or oral glucose tolerance test) or as demonstrated by use of anti-hyperglycemic medications or insulin.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study Summary

This trial will test whether a weight-loss drug can help obese and diabetic people with kidney stones made of uric acid or a mix of uric acid and calcium.

Who is the study for?
This trial is for obese individuals with a BMI over 30 who have diabetes or prediabetes and recurrent uric acid kidney stones. They must not have unstable heart conditions, uncontrolled blood pressure, hyperthyroidism, severe depression, current drug/alcohol abuse, chronic kidney disease with eGFR < 60, active cancer treatment or be non-ambulatory.Check my eligibility
What is being tested?
The study tests if phentermine/topiramate can help people with obesity and diabetes who get uric acid kidney stones. Participants are randomly chosen to either receive this medication combo or stick to their usual treatments like citrate salts and allopurinol for an 18-month period.See study design
What are the potential side effects?
Phentermine may cause increased heart rate, dry mouth, restlessness while topiramate might lead to tingling in the hands/feet, weight loss, altered taste sensation. Both drugs together could potentially affect mood and energy levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have type 2 diabetes or pre-diabetes, diagnosed through tests or because I'm on medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Kidney stone growth (mm2) as determined by non-contrast CT scan
New kidney stone formation (mm2) as determined by non-contrast CT scan
Secondary outcome measures
Change in hemoglobin A1c
Change in urinary calcium parameters
Change in urinary citrate parameters
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Allocated to intervention/treatmentExperimental Treatment1 Intervention
Daily phentermine/topiramate x 18 months
Group II: Allocated to pragmatic controlActive Control1 Intervention
Remain on their current regimen

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,656 Total Patients Enrolled
36 Trials studying Obesity
26,923 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,315,026 Total Patients Enrolled
446 Trials studying Obesity
588,898 Patients Enrolled for Obesity
Benjamin Canales, MDPrincipal InvestigatorUniversity of Florida
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Allopurinol (Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04621929 — Phase 3
Obesity Research Study Groups: Allocated to intervention/treatment, Allocated to pragmatic control
Obesity Clinical Trial 2023: Allopurinol Highlights & Side Effects. Trial Name: NCT04621929 — Phase 3
Allopurinol (Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04621929 — Phase 3
Obesity Patient Testimony for trial: Trial Name: NCT04621929 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If a potential patient is over 45, are they eligible for this treatment?

"This study is enrolling individuals over the age of 18 and younger than 75."

Answered by AI

What diseases or conditions is Phentermine / Topiramate Oral Product commonly used as a treatment for?

"Phentermine / Topiramate Oral Product can be used to alleviate the symptoms of acidosis, blood sample storage, and urine alkalinization therapy."

Answered by AI

Are patients being accepted into the trial at this time?

"From our understanding, this study is still recruiting patients. This is based on the information available on clinicaltrials.gov; where it states that the study was posted on 3/31/2021 and edited on the same day."

Answered by AI

What are the primary objectives of this research?

"The primary focus of this long-term study is observing changes in kidney stone growth as measured by non-contrast CT scan. Additionally, researchers will also be collecting data on changes in urinary citrate (percent change), urine pH levels (absolute change), and urinary calcium (percentage change)."

Answered by AI

How many subjects are enrolled in this research project?

"That is correct. As of today, this study is still looking for 39 individuals to participate at 1 location. The listing was first created on March 31st, 2021 and has not been updated since then."

Answered by AI

How can I join this clinical trial?

"This clinical trial is looking for 39 participants who have impaired glucose tolerance and meet the following criteria: -Have recurrent pure uric acid nephrolithiasis (UAN) or mixed calcium oxalate (CO)/UAN. Recurrent stone disease is defined as at least two spontaneous kidney stone passages, two previous kidney stone procedures, or one previous stone passage and one previous procedure. Pure UAN is defined as at least one previous stone analysis demonstrating 100% uric acid mineral content. Mixed COUAN will be defined as at least one previous stone analysis with any mix of uric acid ≥80% and"

Answered by AI

Has the FDA given its blessing to Phentermine / Topiramate Oral Product?

"There is some evidence from previous studies to support the efficacy of this medication, as well as data collected from multiple rounds of testing that suggest it is safe. Consequently, we have given it a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
South Carolina
New York
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I was in a car accident that has impaired my ability to exercise and lose weight .
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Obesity and Uric Acid Stones Study
2021. "Obesity and Uric Acid Stones Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04621929.
~10 spots leftby Apr 2025
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