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NCT Number: NCT04333745

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Controlled diet

Other

Participant will consume a controlled low oxalate diet for five days

Carbon-13 Oxalate and Sucralose Ingestion

Dietary Supplement

Subjects will ingest a small amount of carbon-13 oxalate and sucralose, dissolved in water.

Primary outcomes

  1. Urinary Oxalate Excretion

    Time frame: Baseline through Day 5

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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Texas, Southwestern Medical Center at Dallas

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2020
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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