- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04333745
Influence of Obesity on Oxalate Metabolism and Handling in Calcium Oxalate Stone Formers
February 20, 2024 updated by: Dean Assimos, MD, University of Alabama at Birmingham
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
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
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Alabama
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Birmingham, Alabama, United States, 35243-3353
- University of Alabama at Birmingham
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Texas
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Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center
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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
19 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
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: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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Participant will consume a controlled low oxalate diet for five days
Subjects will ingest a small amount of carbon-13 oxalate and sucralose, dissolved in water.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary Oxalate Excretion
Time Frame: Baseline through Day 5
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Urinary oxalate excretion from urine samples will be measured as mg/day
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Baseline through Day 5
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dean Assimos, 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)
September 1, 2021
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
April 1, 2020
First Submitted That Met QC Criteria
April 1, 2020
First Posted (Actual)
April 3, 2020
Study Record Updates
Last Update Posted (Estimated)
February 22, 2024
Last Update Submitted That Met QC Criteria
February 20, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-300004693
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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