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Influence of Obesity on Oxalate Metabolism and Handling in Calcium Oxalate Stone Formers

Primary Purpose

Kidney Stone

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Controlled Diet
Carbon-13 Oxalate and Sucralose Ingestion
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Kidney Stone focused on measuring oxalate, kidney stone

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Normal Body Mass Index (≥ 18.5 to < 25); Obese Body Mass Index (≥ 30 to ≤ 45)
  • Able to provide informed consent
  • Willingness to consume controlled diet
  • Composition of most recent stone > 50% calcium oxalate, no uric acid component
  • First time or recurrent calcium oxalate stone former
  • 24-hour urine collections with creatinine values within 20% of appropriate ratio of creatinine (mg)/body weight (kg) for gender, and with creatinine values that are consistent between collections (within 20% of each other)
  • Willingness to stop supplements [vitamins, Ca (citrate or carbonate) and other minerals, herbal supplements, nutritional aids, probiotics] for 14 days before start and during study
  • Willingness to not undertake vigorous exercise during the controlled dietary study
  • Normal fasting blood Comprehensive Metabolic Panel
  • Hemoglobin A1c < 6.5%
  • No food allergies or intolerance to any of the food in study menus
  • Permitted/willing to discontinue medications for kidney stone prevention, including thiazides, allopurinol, and febuxostat and citrate preparations, for 14 days before start and during the studies. They will be instructed to restart these medications at the conclusion of the study

Exclusion Criteria:

  • Diabetes
  • Abnormal fasting comprehensive metabolic panel (CMP)
  • Hemoglobin A1c (HbA1c) result ≥ 6.5%
  • Gout
  • Estimated Glomerular Filtration Rate (eGFR) <60 ml/min/1.73m^2
  • Primary hyperoxaluria
  • Cystic fibrosis
  • Cystinuria
  • Uric acid stone former
  • Utilization of immunosuppressive medication
  • Nephrotic syndrome
  • Enteric hyperoxaluria
  • Gastrointestinal disorder that could impact oxalate transport
  • Sarcoidosis
  • Uncontrolled hypertension
  • Renal tubular acidosis
  • Primary hyperparathyroidism
  • Liver disease
  • Neurogenic bladder
  • Urinary diversion
  • Chronic diarrhea
  • Bariatric surgery
  • Active malignancy or treatment for malignancy within 12 months prior to screening
  • Pregnancy
  • Breast feeding/nursing
  • Females of child bearing age who are not able to use an effective method of birth control during the study
  • Mental/medical condition that is likely to impede successful study completion
  • Illness including flu / common cold / fever 14 days before study and during study
  • Diarrhea or other abnormal gastrointestinal event (e.g. abnormal bowel movements) 14 days before study or during study
  • Antibiotic use within last 6 months (based on recommendations of the NIH Human Microbiome Project, Protocol A)
  • Inability or unwillingness to undergo MRI

Sites / Locations

  • University of Alabama at Birmingham
  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Controlled Dietary Study

Arm Description

Participants will consume the controlled diet for five days. After one day on the diet, subjects will provide three 24-hour urine collections. On the last dayof the diet, subjects will come in a fasted state to ingest a small amount of carbon-13 oxalate and sucralose, with hourly urine collections and blood samples being taken before and after the ingestion.

Outcomes

Primary Outcome Measures

Urinary Oxalate Excretion
Urinary oxalate excretion from urine samples will be measured as mg/day

Secondary Outcome Measures

Full Information

First Posted
April 1, 2020
Last Updated
September 11, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04333745
Brief Title
Influence of Obesity on Oxalate Metabolism and Handling in Calcium Oxalate Stone Formers
Official Title
Influence of Obesity on Oxalate Metabolism and Handling in Calcium Oxalate Stone Formers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
December 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
The primary goals of this study are to determine the contribution of dietary oxalate absorption, renal oxalate handling, and endogenous oxalate synthesis to urinary oxalate excretion in normal Body Mass Index (BMI) and obese calcium oxalate kidney stone formers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone
Keywords
oxalate, kidney stone

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Controlled Dietary Study
Arm Type
Experimental
Arm Description
Participants will consume the controlled diet for five days. After one day on the diet, subjects will provide three 24-hour urine collections. On the last dayof the diet, subjects will come in a fasted state to ingest a small amount of carbon-13 oxalate and sucralose, with hourly urine collections and blood samples being taken before and after the ingestion.
Intervention Type
Other
Intervention Name(s)
Controlled Diet
Intervention Description
Participant will consume a controlled low oxalate diet for five days
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbon-13 Oxalate and Sucralose Ingestion
Intervention Description
Subjects will ingest a small amount of carbon-13 oxalate and sucralose, dissolved in water.
Primary Outcome Measure Information:
Title
Urinary Oxalate Excretion
Description
Urinary oxalate excretion from urine samples will be measured as mg/day
Time Frame
Baseline through Day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Normal Body Mass Index (≥ 18.5 to < 25); Obese Body Mass Index (≥ 30 to ≤ 45) Able to provide informed consent Willingness to consume controlled diet Composition of most recent stone > 50% calcium oxalate, no uric acid component First time or recurrent calcium oxalate stone former 24-hour urine collections with creatinine values within 20% of appropriate ratio of creatinine (mg)/body weight (kg) for gender, and with creatinine values that are consistent between collections (within 20% of each other) Willingness to stop supplements [vitamins, Ca (citrate or carbonate) and other minerals, herbal supplements, nutritional aids, probiotics] for 14 days before start and during study Willingness to not undertake vigorous exercise during the controlled dietary study Normal fasting blood Comprehensive Metabolic Panel Hemoglobin A1c < 6.5% No food allergies or intolerance to any of the food in study menus Permitted/willing to discontinue medications for kidney stone prevention, including thiazides, allopurinol, and febuxostat and citrate preparations, for 14 days before start and during the studies. They will be instructed to restart these medications at the conclusion of the study Exclusion Criteria: Diabetes Abnormal fasting comprehensive metabolic panel (CMP) Hemoglobin A1c (HbA1c) result ≥ 6.5% Gout Estimated Glomerular Filtration Rate (eGFR) <60 ml/min/1.73m^2 Primary hyperoxaluria Cystic fibrosis Cystinuria Uric acid stone former Utilization of immunosuppressive medication Nephrotic syndrome Enteric hyperoxaluria Gastrointestinal disorder that could impact oxalate transport Sarcoidosis Uncontrolled hypertension Renal tubular acidosis Primary hyperparathyroidism Liver disease Neurogenic bladder Urinary diversion Chronic diarrhea Bariatric surgery Active malignancy or treatment for malignancy within 12 months prior to screening Pregnancy Breast feeding/nursing Females of child bearing age who are not able to use an effective method of birth control during the study Mental/medical condition that is likely to impede successful study completion Illness including flu / common cold / fever 14 days before study and during study Diarrhea or other abnormal gastrointestinal event (e.g. abnormal bowel movements) 14 days before study or during study Antibiotic use within last 6 months (based on recommendations of the NIH Human Microbiome Project, Protocol A) Inability or unwillingness to undergo MRI
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
35243-3353
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

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Influence of Obesity on Oxalate Metabolism and Handling in Calcium Oxalate Stone Formers

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