NCT04333745Active, not recruiting
Influence of Obesity on Oxalate Metabolism and Handling in Calcium Oxalate Stone Formers
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 22 (actual)
- First submitted
- 1 Apr 2020
- Start date
- 1 Sept 2021
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Obesity
- NCT number
- NCT04333745
What you commit to
- Study type: Interventional
- Participants enrolled: 22
- From 1 Sept 2021 to the primary completion date, 1 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Utilization of immunosuppressive medication
- Bariatric surgery
- Active malignancy or treatment for malignancy within 12 months prior to screening
- 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
Other illness
- Diabetes
- Nephrotic syndrome
- Gastrointestinal disorder that could impact oxalate transport
- Uncontrolled hypertension
- Liver disease
- Mental/medical condition that is likely to impede successful study completion
Lab values
- Hemoglobin A1c (HbA1c) result ≥ 6.5%
- Estimated Glomerular Filtration Rate (eGFR) \<60 ml/min/1.73m\^2
Age
- Females of child bearing age who are not able to use an effective method of birth control during the study
Other
- Abnormal fasting comprehensive metabolic panel (CMP)
- Gout
- Primary hyperoxaluria
- Cystic fibrosis
- Cystinuria
- Uric acid stone former
- Enteric hyperoxaluria
- Sarcoidosis
- Renal tubular acidosis
- Primary hyperparathyroidism
- Neurogenic bladder
- Urinary diversion
- Chronic diarrhea
- Pregnancy
- Breast feeding/nursing
- Antibiotic use within last 6 months (based on recommendations of the NIH Human Microbiome Project, Protocol A)
- Inability or unwillingness to undergo MRI
Who the study is looking for
- 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
Age in the registry: 19 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.