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Influence of Obesity on Endogenous Oxalate Synthesis

Primary Purpose

Kidney Stone

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
controlled diet
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Stone

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 25-60 years
  • Body Mass Index (BMI) <50

Exclusion Criteria:

  • history of kidney stones
  • history of diabetes, hepatic disease, renal disease including Chronic Kidney Disease (CKD), bowel disease or other endocrine disorders
  • pregnant or lactating women, or those with the intention to become pregnant in the near future
  • abnormal liver enzymes
  • hemoglobin A1C > 6.5

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

20-24.9 BMI

25-29.9 BMI

30-34.9 BMI

35-39.9 BMI

40-44.9 BMI

45-50 BMI

Arm Description

Participants with a BMI that falls between 20 and 24.9 who will receive the controlled diet

Participants with a BMI that falls between 25 and 29.9 who will receive the controlled diet

Participants with a BMI that falls between 30 and 34.9 who will receive the controlled diet

Participants with a BMI that falls between 35 and 39.9 who will receive the controlled diet

Participants with a BMI that falls between 40 and 44.9 who will receive the controlled diet

Participants with a BMI that falls between 45 and 50 who will receive the controlled diet.

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
October 3, 2018
Last Updated
August 14, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03704350
Brief Title
Influence of Obesity on Endogenous Oxalate Synthesis
Official Title
Influence of Obesity on Endogenous Oxalate Synthesis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

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
There is increasing evidence that obesity is associated with increased urinary oxalate excretion, an important risk factor for calcium oxalate stone formation. By the administration of a controlled low oxalate diet the investigators will estimate endogenous oxalate synthesis in both non-obese and obese non-kidney-stone forming adults. This study seeks to thusly increase the understanding of the relationships between obesity and endogenous oxalate synthesis to serve as a platform to develop novel therapies for stone prevention.
Detailed Description
Calcium oxalate stone disease results in billions of dollars in healthcare costs per year, creates large economic losses due to decreased work productivity, and produces significant pain and suffering in affected individuals impacting quality of life. Almost 9% of the population in the United States may now experience a stone event at least once in their lifetime and that figure is increasing. Although stone removing treatments have advanced in the last few decades with a variety of minimally invasive procedures such as shock wave lithotripsy, ureteroscopy and percutaneous nephrolithotomy, our knowledge of how stones form and how to prevent them has not kept pace. Approximately 70-80% of the stones formed contain oxalate. Oxalate is an end product of metabolism and an ubiquitous element of human diets. Small increases in urinary oxalate can increase calcium oxalate crystal formation and thus stone disease. Urinary oxalate levels are affected by both dietary and endogenous components, complicating the discrimination between the two sources. Multiple epidemiological and clinical studies have demonstrated a link between body mass index (BMI) and kidney stone disease and also an increased urinary oxalate excretion. The interpretation of studies suggesting a link between obesity and the amount of urinary oxalate excreted is confounded by the failure in most studies to use diets controlled in calcium and oxalate. Adult humans without a history of kidney stones will be placed on controlled low oxalate diets to estimate the contribution of endogenous oxalate synthesis to the urinary oxalate pool. In addition, oral doses of 13C2-glycolate and 13C6- vitamin C will be used to determine their conversions to 13C2-oxalate and provide an index of endogenous oxalate production. Body morphometric indices, markers of oxidative stress, and insulin resistance will be assessed in these subjects.They will also be evaluated with DXA and MRI to define body fat content and distribution.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
20-24.9 BMI
Arm Type
Active Comparator
Arm Description
Participants with a BMI that falls between 20 and 24.9 who will receive the controlled diet
Arm Title
25-29.9 BMI
Arm Type
Active Comparator
Arm Description
Participants with a BMI that falls between 25 and 29.9 who will receive the controlled diet
Arm Title
30-34.9 BMI
Arm Type
Active Comparator
Arm Description
Participants with a BMI that falls between 30 and 34.9 who will receive the controlled diet
Arm Title
35-39.9 BMI
Arm Type
Active Comparator
Arm Description
Participants with a BMI that falls between 35 and 39.9 who will receive the controlled diet
Arm Title
40-44.9 BMI
Arm Type
Active Comparator
Arm Description
Participants with a BMI that falls between 40 and 44.9 who will receive the controlled diet
Arm Title
45-50 BMI
Arm Type
Active Comparator
Arm Description
Participants with a BMI that falls between 45 and 50 who will receive the controlled diet.
Intervention Type
Dietary Supplement
Intervention Name(s)
controlled diet
Intervention Description
Participants will consume a diet that is controlled in its daily contents of oxalate, calcium, vitamin C and sodium, and in its content of carbohydrate, fat, and protein. Participants will be asked not to take any dietary supplements (vitamins, calcium or other minerals, herbal supplements, nutritional aids), to exercise strenuously, or to consume food or drink that is not provided to them as part of the controlled diet.
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 Day 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 25-60 years Body Mass Index (BMI) <50 Exclusion Criteria: history of kidney stones history of diabetes, hepatic disease, renal disease including Chronic Kidney Disease (CKD), bowel disease or other endocrine disorders pregnant or lactating women, or those with the intention to become pregnant in the near future abnormal liver enzymes hemoglobin A1C > 6.5
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sonia Fargue, MD PhD
Phone
205-934-0169
Email
sfargue@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dean Assimos, 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
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Fargue, MD
Phone
205-934-0169
Email
sfargue@uab.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Influence of Obesity on Endogenous Oxalate Synthesis

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