Obesity and Endogenous Oxalate Synthesis

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Recruiting

CT.gov ID

NCT03808090

Collaborator

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

120

Enrollment

Location

Arms

120

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Kidney Stone	Other: Normal Individuals Other: Calcium Oxalate Kidney Stone Formers Other: Type 2 Diabetes Other: Type 2 diabetic kidney stone formers	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Obesity and Endogenous Oxalate Synthesis

Actual Study Start Date :

Jan 1, 2013

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Urinary oxalate excretion [Baseline through 2 months]
Urinary oxalate excretion from 24 hour urine collections will be reported as mg/day

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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