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

Running, not enrolling · Not applicable

Conditions studied: Kidney Stone

In brief

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.

Key facts

Study ID

NCT04333745

Run by

University of Alabama at Birmingham

People needed

22

Starts

2021-09-01

Expected to finish

2026-12-01

Last updated by the study team

2026-03-09

Who can join

Age: 19 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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