Examining how metabolic syndrome affects oxalate production
Non Alcoholic Fatty Liver Disease and Endogenous Oxalate Synthesis
NA · University of Alabama at Birmingham · NCT06735924
This study is testing how metabolic syndrome affects the body's production of oxalate in people with liver disease by having them follow a low-oxalate diet and collecting urine samples.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham (other) |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06735924 on ClinicalTrials.gov |
What this trial studies
This study investigates the daily rate of endogenous oxalate synthesis in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) by utilizing a low-oxalate controlled diet and collecting fasted urine samples. Participants will undergo repeat fasted urine collections and 24-hour urine collections to accurately measure oxalate levels. The goal is to understand the relationship between metabolic syndrome and oxalate metabolism, which could have implications for managing MASLD.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a history of MASLD and liver fat content greater than 5%.
Not a fit: Patients with liver cirrhosis or other chronic liver diseases, as well as those with uncontrolled diabetes or significant kidney issues, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary recommendations and management strategies for patients with MASLD.
How similar studies have performed: While the specific approach of measuring endogenous oxalate synthesis in MASLD is novel, related studies on metabolic syndrome and dietary impacts have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)
Study contacts
- Principal investigator: Kyle D Wood, MD — University of Alabama at Birmingham
- Study coordinator: Kyle D Wood, MD
- Email: kylewood@uabmc.edu
- Phone: 2059968765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: MASLD, Metabolic Dysfunction-Associated Steatotic Liver Disease, oxalate synthesis, oxalate metabolism