Influence of Metabolic Syndrome on Endogenous Oxalate Synthesis

Not Applicable

Recruiting

• Conditions: MASLD; Metabolic Dysfunction-Associated Steatotic Liver Disease

• Registration Number: NCT06735924
• Lead Sponsor: University of Alabama at Birmingham

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).

Study Timeline

• Study Start: 2023-04-26
• Status Verified: 2024-12
• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-14
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States