NCT04633811Active, not recruiting
Effect of Weight Loss on Urinary Oxalate Excretion in Obese Calcium Oxalate Kidney Stone Formers
Effect of Weight Loss on Urinary Oxalate Excretion in Obese Calcium Oxalate Kidney Stone
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
This protocol seeks to determine if weight reduction with the Optifast VLCD program leads to reduced contribution of endogenous oxalate synthesis and dietary oxalate absorption to the urinary oxalate pool in obese calcium oxalate stone formers.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 11 Nov 2020
- Start date
- 3 Dec 2021
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Obesity
- NCT number
- NCT04633811
What you commit to
- Study type: Interventional
- Participants enrolled: 14
- From 3 Dec 2021 to the primary completion date, 31 Dec 2025
- 1 site 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
- Renal colic or past stone surgery in the past 3 months
- Alcohol or drug abuse. Alcohol consumption \>12 units per week and/or unwillingness to abstain from alcohol consumption 2 days before and during the study.
- Medications: Topiramate, acetazolamide, zonisamide, diuretics, SGLT2-inhibitors, immunosuppressants
Other illness
- History of type 2 diabetes or screening hgb A1c greater than or equal to 6.5%
- Mental/medical condition likely to impede study completion
- Febrile illness including flu/common cold/COVID-19 within 21 days of study start
- Gastrointestinal disorder or surgery that impacts oxalate transport
- Cirrhosis, pancreatic or biliary disorder, porphyria, gout
- Malignancy treated within the past 12 months
- Nephrotic syndrome, neurogenic bladder, urinary diversion
- History of primary hyperparathyroidism, cystinuria, renal tubular acidosis, sarcoidosis, cystic fibrosis
- Uncontrolled hypertension, myocardial infarction in past 6 months, unstable angina, congestive heart failure
Lab values
- Estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73m2
Other
- Current/planned pregnancy or breastfeeding in coming 6 months, unwillingness to use effective method of birth control during the study for individuals of childbearing potential.
- Planned vacation in coming 4 months
- Primary or enteric hyperoxaluria
Who the study is looking for
- First time or recurrent calcium oxalate stone formers defined as composition of most recent stone \>50% calcium oxalate without uric acid component
- Last stone passage or removal greater than 3 months prior to screening
- Body Mass Index (BMI) \>35 kg/m2
- Able to provide consent
- Hemoglobin A1C \<6.5%
- Normal fasting blood CMP: Normal serum Na, K, Cl, CO2, Calcium, Albumin, AST, ALT \<2 times upper limit of normal, Glucose \<126 mg/dl, eGFR \>60 ml/min/1.73 m2.
- 24-hour urine collection with creatinine within 20% of gender appropriate (mg creat/kg body weight) and consistent between collections (within 20% of each other)
- Willing to ingest menus prepared at the University of Alabama and University of Texas Southwestern Clinical Research Units
- Willing to consume the Optifast VLCD diet
- Willing to ingest menus prepared in Metabolic kitchen. No food allergies or intolerance to any of the foods in study menus. Substitutions for lactose intolerance will be made.
- Willing to avoid vigorous exercise during eucaloric, low-oxalate dietary phase
- Willing to stop use of weight-loss medications
- Willing to stop for 14 days before and during study: medications for stone prevention including diuretics, potassium citrate, allopurinol, febuxostat, and calcium, nutritional, or herbal supplements
- Those with controlled hypertension (systolic blood pressure \<160 mmHg, diastolic \<90 mmHg) will be included.
- Those without severe dyslipidemia (LDL \<200 mg/dL, HDL \>30 mg/dL, and triglycerides \<250 mg/dL) will be included. Treated and controlled dyslipidemia is accepted
- Smoking/chewing tobacco/vaping will be allowed
Age in the registry: 19 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
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 |
This page is information, not medical advice. Discuss any trial with your doctor.