Obesity and Endogenous Oxalate Synthesis

July 19, 2023 updated by: Kyle D. Wood, University of Alabama at Birmingham
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

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

Investigators

  • Principal Investigator: Kyle D Wood, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

July 1, 2023

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

December 26, 2018

First Submitted That Met QC Criteria

January 16, 2019

First Posted (Actual)

January 17, 2019

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-130502007
  • 1K08DK115833-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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