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Obesity and Oxalate Production in Kidney Stones

N/A
Waitlist Available
Led By Kyle D Wood, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Calcium oxalate stone formers with passage or removal of a kidney stone containing > 50% calcium oxalate
Type 2 Diabetics with fasting glucose > 126 mg/dL or hemoglobin A1c greater than or equal to 6.5%
Must not have
A glomerular filtration rate (GFR) or estimated GFR < 60 mls/min
Any disease that will affect the urinary excretion of oxalate, calcium or another ion that will compromise the interpretation of results
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days on fixed diet
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how obesity affects the amount of oxalate in urine, which contributes to calcium oxalate kidney stones.

Who is the study for?
This trial is for adults with a BMI under 30 who have had kidney stones made mostly of calcium oxalate, and those with Type 2 Diabetes showing specific blood sugar levels. It's not for pregnant individuals, people with abnormal urine or blood tests that could affect the study results, anyone with poor kidney function (GFR < 60), or a BMI over 32.
What is being tested?
The study aims to understand how obesity affects urinary oxalate levels and the formation of calcium oxalate kidney stones. It will explore this link in different groups: non-obese individuals, obese stone formers, and diabetics.
What are the potential side effects?
Since this trial seems observational rather than interventional—meaning it observes participants without administering treatments—there are no direct side effects from medications or procedures listed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have passed or had removed a kidney stone that is mostly made of calcium oxalate.
Select...
I have type 2 diabetes with high blood sugar or A1c levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My kidney function is reduced, with a GFR under 60.
Select...
I do not have a condition that affects how my body gets rid of certain substances in urine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days on fixed diet
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days on fixed diet for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Urinary Oxalate Excretion
Secondary study objectives
Urinary Creatinine Excretion
Urinary Glycolate Excretion

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Normal IndividualsExperimental Treatment1 Intervention
Normal individuals: no prior history of kidney stones
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Normal Individuals
2013
N/A
~60

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,432 Previous Clinical Trials
4,323,199 Total Patients Enrolled
467 Trials studying Obesity
589,441 Patients Enrolled for Obesity
University of Alabama at BirminghamLead Sponsor
1,636 Previous Clinical Trials
2,305,096 Total Patients Enrolled
72 Trials studying Obesity
468,461 Patients Enrolled for Obesity
National Institutes of Health (NIH)NIH
2,805 Previous Clinical Trials
8,150,268 Total Patients Enrolled
106 Trials studying Obesity
26,656 Patients Enrolled for Obesity

Media Library

Normal Individuals Clinical Trial Eligibility Overview. Trial Name: NCT03808090 — N/A
Obesity Research Study Groups: Normal Individuals
Obesity Clinical Trial 2023: Normal Individuals Highlights & Side Effects. Trial Name: NCT03808090 — N/A
Normal Individuals 2023 Treatment Timeline for Medical Study. Trial Name: NCT03808090 — N/A
~5 spots leftby Oct 2025
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