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Obesity and Oxalate Production in Kidney Stones

Q: 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.

Q: 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%.

Q: 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.

Q: 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.

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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 2 months

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,357 Previous Clinical Trials

4,315,126 Total Patients Enrolled

446 Trials studying Obesity

588,878 Patients Enrolled for Obesity

University of Alabama at BirminghamLead Sponsor

1,584 Previous Clinical Trials

2,280,014 Total Patients Enrolled

72 Trials studying Obesity

474,070 Patients Enrolled for Obesity

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,520 Total Patients Enrolled

103 Trials studying Obesity

25,796 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

Recent research and studies

clinicaltrials.govStudy

Obesity and Endogenous Oxalate Synthesis

Kyle D. Wood 2013. "Obesity and Endogenous Oxalate Synthesis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03808090.

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