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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 baseline through 2 months
Awards & highlights

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.Check my eligibility
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.See study design
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
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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 ~baseline through 2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 2 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
Urinary oxalate excretion

Trial Design

4Treatment groups
Experimental Treatment
Group I: Type 2 diabetic kidney stone formersExperimental Treatment1 Intervention
Those individuals that have been diagnosed with type 2 diabetes and kidney stones.
Group II: Type 2 DiabetesExperimental Treatment1 Intervention
Those individuals that have been diagnosed with type 2 diabetes
Group III: Normal IndividualsExperimental Treatment1 Intervention
Normal individuals: no prior history of KS, no obesity, no diabetes
Group IV: Calcium Oxalate Kidney Stone FormersExperimental Treatment1 Intervention
Those individuals that have a high propensity to form calcium oxalate kidney stones

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,381 Previous Clinical Trials
4,315,042 Total Patients Enrolled
453 Trials studying Obesity
588,905 Patients Enrolled for Obesity
University of Alabama at BirminghamLead Sponsor
1,599 Previous Clinical Trials
2,287,860 Total Patients Enrolled
72 Trials studying Obesity
474,218 Patients Enrolled for Obesity
National Institutes of Health (NIH)NIH
2,736 Previous Clinical Trials
7,507,890 Total Patients Enrolled
105 Trials studying Obesity
26,096 Patients Enrolled for Obesity

Media Library

Calcium Oxalate Kidney Stone Formers Clinical Trial Eligibility Overview. Trial Name: NCT03808090 — N/A
Obesity Research Study Groups: Normal Individuals, Calcium Oxalate Kidney Stone Formers, Type 2 Diabetes, Type 2 diabetic kidney stone formers
Obesity Clinical Trial 2023: Calcium Oxalate Kidney Stone Formers Highlights & Side Effects. Trial Name: NCT03808090 — N/A
Calcium Oxalate Kidney Stone Formers 2023 Treatment Timeline for Medical Study. Trial Name: NCT03808090 — N/A
~5 spots leftby Jul 2025
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