MASLD, Metabolic Dysfunction-Associated Steatotic Liver Disease
Conditions
Keywords
oxalate synthesis, oxalate metabolism, MASLD
Brief 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).
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).
Interventions
DIETARY_SUPPLEMENTLow-oxalate fixed diet
Ingestion of a low-oxalate (\< 60 mg/day) , normal calcium (800-1200 mg/d) eucaloric diet for 5 days
Sponsors
University of Alabama at Birmingham
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| estimated endogenous oxalate synthesis rate | 1 day | Average fasted hourly urinary oxalate excretion rate normalized to urinary creatinine excretion (mg oxalate / g urinary creatinine) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Oxalate excretion | 2 days | average urinary oxalate excretion rate normalized to urinary creatinine after equilibration on a low-oxalate fixed diet (mg urinary oxalate / g urinary creatinine) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKyle D Wood, MD
University of Alabama at Birmingham
Outcome results
None listed