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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04333745
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : September 13, 2022
Sponsor:
Information provided by (Responsible Party):
Dean Assimos, MD, University of Alabama at Birmingham

Study Description
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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.

Condition or disease Intervention/treatment Phase
Kidney Stone Other: Controlled Diet Dietary Supplement: Carbon-13 Oxalate and Sucralose Ingestion Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Influence of Obesity on Oxalate Metabolism and Handling in Calcium Oxalate Stone Formers
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Sucralose

Arms and Interventions
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Arm Intervention/treatment
Experimental: Controlled Dietary Study
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.
 Other: Controlled Diet
Participant will consume a controlled low oxalate diet for five days

Dietary Supplement: Carbon-13 Oxalate and Sucralose Ingestion
Subjects will ingest a small amount of carbon-13 oxalate and sucralose, dissolved in water.


Outcome Measures
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Primary Outcome Measures :
  1. Urinary Oxalate Excretion [ Time Frame: Baseline through Day 5 ]
    Urinary oxalate excretion from urine samples will be measured as mg/day


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04333745


Contacts
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Contact: Demond Wiley 205-934-3671 kidneystone@uabmc.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35243-3353
Contact: Demond Wiley    205-934-3671    kidneystone@uabmc.edu   
Principal Investigator: Dean Assimos         
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Sudeepa Bhattacharya       Sudeepa.Bhattacharya@UTSouthwestern.edu   
Principal Investigator: Naim Maalouf, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Dean Assimos, MD University of Alabama at Birmingham
More Information
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Responsible Party: Dean Assimos, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04333745    
Other Study ID Numbers: IRB-300004693
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: September 13, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dean Assimos, MD, University of Alabama at Birmingham:
oxalate
kidney stone
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
 Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi