Influence of Obesity on Oxalate Metabolism and Handling in Calcium Oxalate Stone Formers
NCT ID: NCT04333745
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
22 participants
INTERVENTIONAL
2021-09-01
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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.
Controlled Diet
Participant will consume a controlled low oxalate diet for five days
Carbon-13 Oxalate and Sucralose Ingestion
Subjects will ingest a small amount of carbon-13 oxalate and sucralose, dissolved in water.
Interventions
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Controlled Diet
Participant will consume a controlled low oxalate diet for five days
Carbon-13 Oxalate and Sucralose Ingestion
Subjects will ingest a small amount of carbon-13 oxalate and sucralose, dissolved in water.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
75 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Texas, Southwestern Medical Center at Dallas
OTHER
University of Alabama at Birmingham
OTHER
Responsible Party
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Dean Assimos, MD
Principal Investigator
Principal Investigators
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Dean Assimos, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
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Other Identifiers
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UAB
Identifier Type: OTHER
Identifier Source: secondary_id
IRB300004693-OHM
Identifier Type: -
Identifier Source: org_study_id