Obesity and Endogenous Oxalate Synthesis

Study Overview
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Brief Summary
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The goal of this proposal is to determine the contribution and significance of obesity to urinary oxalate excretion and thus calcium oxalate kidney stone disease. Successful completion of the study will provide insight into the link between obesity and kidney stone disease and should identify future strategies to treat this disease.

Official Title
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Obesity and Endogenous Oxalate Synthesis

Conditions
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Obesity, Kidney Stone

Intervention / Treatment
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* Other: Normal Individuals
* Other: Calcium Oxalate Kidney Stone Formers
* Other: Type 2 Diabetes
* Other: Type 2 diabetic kidney stone formers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index (BMI) < 30 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% Exclusion Criteria: Any disease that will affect the urinary excretion of oxalate, calcium or another ion that will compromise the interpretation of results. Abnormal urine chemistries or blood metabolic profiles A glomerular filtration rate (GFR) or estimated GFR < 60 mls/min Pregnancy Body Mass Index (BMI) > 32

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal Individuals<br>Normal individuals: no prior history of KS, no obesity, no diabetes | Other: Normal Individuals<br>* Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver<br>|
| Experimental: Calcium Oxalate Kidney Stone Formers<br>Those individuals that have a high propensity to form calcium oxalate kidney stones | Other: Calcium Oxalate Kidney Stone Formers<br>* Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver<br>|
| Experimental: Type 2 Diabetes<br>Those individuals that have been diagnosed with type 2 diabetes | Other: Type 2 Diabetes<br>* Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver<br>|
| Experimental: Type 2 diabetic kidney stone formers<br>Those individuals that have been diagnosed with type 2 diabetes and kidney stones. | Other: Type 2 diabetic kidney stone formers<br>* Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary oxalate excretion | Urinary oxalate excretion from 24 hour urine collections will be reported as mg/day | Baseline through 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxalate, obesity, kidney stones, diabetes