Weight loss may curb kidney stone risk in obese patients
NCT ID NCT04633811
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times
Summary
This study looks at whether losing weight with a special very low-calorie diet (Optifast) can lower oxalate levels in urine for obese adults who have had calcium oxalate kidney stones. Fourteen participants will eat a low-oxalate diet and provide urine samples before and after the weight loss program. The goal is to see if weight reduction reduces the body's own oxalate production and helps manage stone risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
14 people
The number who actually took part.
- Started
-
Dec 2021
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * Renal colic or past stone surgery in the past 3 months * Estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73m2 * History of type 2 diabetes or screening hgb A1c greater than or equal to 6.5% * 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. * Mental/medical condition likely to impede study completion * 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 * Febrile illness including flu/common cold/COVID-19 within 21 days of study start * Primary or enteric hyperoxaluria * 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 * Medications: Topiramate, acetazolamide, zonisamide, diuretics, SGLT2-inhibitors, immunosuppressants
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Kidney stone are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Alabama at Birmingham
Birmingham, Alabama, 35243, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Which emergency drainage gives the best kidney stone surgery results?
- Can a One-Day catheter beat the stent for kidney stone recovery?
- A new standard for pain pills after kidney stone surgery?
- Can watching and waiting beat surgery for silent kidney stones?
- New flexible suction sheath may improve kidney stone removal in children
- Could your diet trigger kidney stones by changing your immune system?