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Obesity and Endogenous Oxalate Synthesis

Primary Purpose

Obesity, Kidney Stone

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Normal Individuals
Calcium Oxalate Kidney Stone Formers
Type 2 Diabetes
Type 2 diabetic kidney stone formers
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity focused on measuring oxalate, obesity, kidney stones, diabetes

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Normal Individuals

Calcium Oxalate Kidney Stone Formers

Type 2 Diabetes

Type 2 diabetic kidney stone formers

Arm Description

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

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

Those individuals that have been diagnosed with type 2 diabetes

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

Outcomes

Primary Outcome Measures

Urinary oxalate excretion
Urinary oxalate excretion from 24 hour urine collections will be reported as mg/day

Secondary Outcome Measures

Full Information

First Posted
December 26, 2018
Last Updated
July 19, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03808090
Brief Title
Obesity and Endogenous Oxalate Synthesis
Official Title
Obesity and Endogenous Oxalate Synthesis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Kidney Stone
Keywords
oxalate, obesity, kidney stones, diabetes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal Individuals
Arm Type
Experimental
Arm Description
Normal individuals: no prior history of KS, no obesity, no diabetes
Arm Title
Calcium Oxalate Kidney Stone Formers
Arm Type
Experimental
Arm Description
Those individuals that have a high propensity to form calcium oxalate kidney stones
Arm Title
Type 2 Diabetes
Arm Type
Experimental
Arm Description
Those individuals that have been diagnosed with type 2 diabetes
Arm Title
Type 2 diabetic kidney stone formers
Arm Type
Experimental
Arm Description
Those individuals that have been diagnosed with type 2 diabetes and kidney stones.
Intervention Type
Other
Intervention Name(s)
Normal Individuals
Intervention Description
Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver
Intervention Type
Other
Intervention Name(s)
Calcium Oxalate Kidney Stone Formers
Intervention Description
Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver
Intervention Type
Other
Intervention Name(s)
Type 2 Diabetes
Intervention Description
Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver
Intervention Type
Other
Intervention Name(s)
Type 2 diabetic kidney stone formers
Intervention Description
Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver
Primary Outcome Measure Information:
Title
Urinary oxalate excretion
Description
Urinary oxalate excretion from 24 hour urine collections will be reported as mg/day
Time Frame
Baseline through 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle D Wood, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Obesity and Endogenous Oxalate Synthesis

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