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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%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 2 months
Awards & highlights
No Placebo-Only Group

Study 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
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.

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

Awards & Highlights

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

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
2,326 Previous Clinical Trials
4,316,168 Total Patients Enrolled
437 Trials studying Obesity
591,615 Patients Enrolled for Obesity
University of Alabama at BirminghamLead Sponsor
1,547 Previous Clinical Trials
2,287,611 Total Patients Enrolled
70 Trials studying Obesity
498,405 Patients Enrolled for Obesity
National Institutes of Health (NIH)NIH
2,662 Previous Clinical Trials
6,694,282 Total Patients Enrolled
99 Trials studying Obesity
25,601 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

Frequently Asked Questions

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

Does the research encompass individuals over seventy-five years of age?

"Individuals between the ages of 19 and 65 are eligible to enroll in this medical trial."

Answered by AI

What criteria must a person fulfill to qualify for participation in this research?

"This medical trial requires 120 patients with kidney stones ranging from 19 to 65 years old. The prerequisites for inclusion necessitate a BMI under 30, calcium oxalate stone formers who have passed or had removed a stone composed of more than 50% calcium oxalate, and type 2 diabetics with fasting glucose surpassing 126 mg/dL or hemoglobin A1c higher than 6.5%."

Answered by AI

What is the capacity of this trial in regards to participant recruitment?

"Affirmative. According to the research posted on clinicaltrials.gov, this medical trial is actively seeking participants since its commencement in January 1st 2013 and its last update from August 17th 2022. The project requires 120 individuals from a single site for completion."

Answered by AI

Is this experiment actively seeking participants at present?

"Affirmative. According to information on clinicaltrials.gov, this research project is actively seeking volunteers for participation; the study was first posted on January 1st 2013 and modified most recently on August 17th 2022. The trial is expecting 120 individuals across a single site."

Answered by AI
~5 spots leftby Feb 2025