Purpose

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).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Estimation of endogenous oxalate production
Fasted hourly urine collections after equilibration on a low-oxalate diet
  • Dietary Supplement: Low-oxalate fixed diet
    Ingestion of a low-oxalate (< 60 mg/day) , normal calcium (800-1200 mg/d) eucaloric diet for 5 days

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Study Coordinator, MS
205-934-5712
kidneystone@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Kyle D Wood, MD
2059968765
kylewood@uabmc.edu

Detailed Description

Urinary oxalate excretion is derived from both dietary sources and endogenous synthesis. This study will use a low-oxalate controlled diet, repeat fasted urine collections and 24-hr urine collections on a low-oxalate diet, to determine the daily rate of endogenous oxalate synthesis in individuals with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.