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Obesity and Oxalate Production in Kidney Stones
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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 belowSelect...
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
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
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Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,376 Previous Clinical Trials
4,315,707 Total Patients Enrolled
451 Trials studying Obesity
588,904 Patients Enrolled for Obesity
University of Alabama at BirminghamLead Sponsor
1,594 Previous Clinical Trials
2,283,035 Total Patients Enrolled
72 Trials studying Obesity
474,218 Patients Enrolled for Obesity
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,167 Total Patients Enrolled
104 Trials studying Obesity
26,032 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your urine or blood tests show unusual chemical or metabolic levels.I have passed or had removed a kidney stone that is mostly made of calcium oxalate.My kidney function is reduced, with a GFR under 60.Your body mass index (BMI) is less than 30.I do not have a condition that affects how my body gets rid of certain substances in urine.I have type 2 diabetes with high blood sugar or A1c levels.Your body mass index (BMI) is higher than 32.
Research Study Groups:
This trial has the following groups:- Group 1: Normal Individuals
- Group 2: Calcium Oxalate Kidney Stone Formers
- Group 3: Type 2 Diabetes
- Group 4: Type 2 diabetic kidney stone formers
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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