Influence of Metabolic Syndrome on Endogenous Oxalate Synthesis

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease; MASLD

Treatments: Dietary Supplement: Low-oxalate fixed diet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06735924

IRB300002318-FLO

UAB (Other Grant/Funding Number)

1R03DK139235-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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).

Enrollment: 28 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Estimation of endogenous oxalate production

Experimental group

Description:

Fasted hourly urine collections after equilibration on a low-oxalate diet

Treatment:

Dietary Supplement: Low-oxalate fixed diet