Obesity and Endogenous Oxalate Synthesis

Obesity and Endogenous Oxalate Synthesis

Sponsors

Lead sponsor: University of Alabama at Birmingham

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

Source University of Alabama at Birmingham
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.

Overall Status Recruiting
Start Date January 1, 2013
Completion Date December 31, 2022
Primary Completion Date December 31, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Urinary oxalate excretion Baseline through 2 months
Enrollment 120
Condition
Intervention

Intervention type: Other

Intervention name: Normal Individuals

Description: Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver

Arm group label: Normal Individuals

Intervention type: Other

Intervention name: Calcium Oxalate Kidney Stone Formers

Description: Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver

Arm group label: Calcium Oxalate Kidney Stone Formers

Intervention type: Other

Intervention name: Type 2 Diabetes

Description: Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver

Arm group label: Type 2 Diabetes

Intervention type: Other

Intervention name: Type 2 diabetic kidney stone formers

Description: Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver

Arm group label: Type 2 diabetic kidney stone formers

Eligibility

Criteria:

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

Gender: All

Minimum age: 19 Years

Maximum age: 65 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Kyle D Wood, MD Principal Investigator University of Alabama at Birmingham
Overall Contact

Last name: Demond Wiley

Phone: 205-934-3671

Email: [email protected]

Location
facility status contact investigator University of Alabama at Birmingham Billy Tingle, RN 205-934-3671 [email protected] Kyle D Wood, MD Principal Investigator
Location Countries

United States

Verification Date

August 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Alabama at Birmingham

Investigator full name: Kyle D. Wood

Investigator title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Arm group label: Normal Individuals

Arm group type: Experimental

Description: Normal individuals: no prior history of KS, no obesity, no diabetes

Arm group label: Calcium Oxalate Kidney Stone Formers

Arm group type: Experimental

Description: Those individuals that have a high propensity to form calcium oxalate kidney stones

Arm group label: Type 2 Diabetes

Arm group type: Experimental

Description: Those individuals that have been diagnosed with type 2 diabetes

Arm group label: Type 2 diabetic kidney stone formers

Arm group type: Experimental

Description: Those individuals that have been diagnosed with type 2 diabetes and kidney stones.

Patient Data Undecided
Study Design Info

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov