Influence of Metabolic Syndrome on Endogenous Oxalate Synthesis (NCT06735924) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Influence of Metabolic Syndrome on Endogenous Oxalate Synthesis
United States28 participantsStarted 2023-04-26
Plain-language summary
This study aims to determine the daily rate of endogenous synthesis of oxalate using fasted urine collection and a low-oxalate controlled diet in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).
Who can participate
Age range
18 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 \>18 years
* History of MASLD, with liver fat content \> 5%
* Normal kidney function
* Stable medication for at least 1 month for diabetes mellitus if any
* Willingess to ingest fixed diets and stop dietary supplements for the study and come to UAB for visits
Exclusion Criteria:
* Age \< 18 years
* Inaccurate 24-hour urine collections
* Liver fat content \<5%
* Liver cirrhosis
* Evidence of other chronic liver disease, viral hepatitis
* history of alcoholism within 2 years of enrollment
* Contra-indication to Magnetic Resonance Imaging
* Chronic kidney disease with estimated Glomerular Filtration rate \< 60 ml/min/1.73m2
* Type 1 Diabetes Mellitus or treatment with insulin
* Uncontrolled diabetes
* Pregnancy, lactation or intention to be
* Uncontrolled hypertension
* Use of weight loss medication, SGLT2 inhibitors, GLP-1 receptor agonists, osteoporosis medication, chronic NSAID
* History of gastric or intestinal surgery or resection that could potentially alter oxalate absorption
* Chronic fat malabsorption
* Use of immunosuppressive medications
* Known immuno-compromised status
* Active malignancy or treatment for malignanacy within the last 12 months
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.