Obesity and Endogenous Oxalate Synthesis

Obesity Clinical Trial

Official title:

Obesity and Endogenous Oxalate Synthesis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03808090
• Other study ID #: IRB-130502007
• Secondary ID: 1K08DK115833-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2013
• Est. completion date: July 31, 2024

Study information

• Verified date: July 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 31, 2024
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Nephrolithiasis
• Obesity

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary oxalate excretion	Urinary oxalate excretion from 24 hour urine collections will be reported as mg/day	Baseline through 2 months