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Weight loss may curb kidney stone risk in obese patients

NCT ID NCT04633811

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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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

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

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Conditions

The condition(s) this trial relates to.

Kidney Calculi nephrolithiasis

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.