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Obesity's hidden role in kidney stones revealed?

NCT ID NCT04333745

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This study looks at how obesity changes the way the body handles oxalate, a substance that can form kidney stones. Researchers will give 22 calcium oxalate stone formers a controlled low-oxalate diet and a special tracer to measure oxalate absorption, kidney handling, and natural production. The goal is to understand why obese people are more prone to kidney stones.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Controlled low oxalate diet and carbon-13 oxalate with sucralose
What this could lead to
If successful, this could help explain why obese people form more kidney stones and point toward better dietary advice or treatments to prevent stones.
What could go wrong
This is a small, early-stage observational study with only 22 participants, so results may not apply to everyone. It does not test a new treatment, only measures metabolism.

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

22 people

The number who actually took part.

Started

Sep 2021

Expected to finish

Aug 2027

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 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * 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

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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, 35243-3353, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

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