CompletedNot Applicable

Obesity and Endogenous Oxalate Synthesis

United States58 participantsStarted 2013-01-01

Plain-language summary

The goal of this study is to determine if obesity is associated with increased endogenous oxalate synthesis as assessed by urinary oxalate excretion, which is a known risk factor for calcium oxalate kidney stones. The study will recruit adult participants without history of kidney stones. Participants will * Ingest fixed diets containing low amounts of oxalate for 4 days * Collect 24-hr urine samples during the fixed diet

Who can participate

Age range

19 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria Age 19-70 yrs Body Mass Index \> 18.5 kg/m2 Normal fasting serum electrolytes on comprehensive metabolic profile Willing to ingest fixed diets Exclusion Criteria Chronic Kidney Disease, estimated glomerular filtration rate \< 60 ml/mn/1.73m2 Primary hyperoxaluria Liver, endocrine or renal diseases or any other condition that may influence the absorption, transport or urinary excretion of ions, which will compromise the interpretation of results, including: Cystic fibrosis, Cystinuria, Uric acid stone former, Nephrotic syndrome, Sarcoidosis, Renal tubular acidosis, Primary hyperparathyroidism, Neurogenic bladder, Urinary diversion Pregnancy or breast-feeding Incompatible dietary requirements with the study, food allergies or intolerance to any of the foods in study menus Active malignancy or treatment for malignancy within 12 months prior to screening Utilization of immunosuppressive medication Uncontrolled Hypertension or diabetes

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Urinary Oxalate Excretion

Timeframe: 3 days on the fixed diet

Trial details

NCT IDNCT03808090

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-01

Results submitted2024-06-28

View on ClinicalTrials.gov More Obesity trials