Influence of Metabolic Syndrome on Endogenous Oxalate Synthesis

Non Alcoholic Fatty Liver Disease and Endogenous Oxalate Synthesis

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).

Study Overview

• Status: Active, not recruiting
• Conditions: MASLD; Metabolic Dysfunction-Associated Steatotic Liver Disease
• Intervention / Treatment: Dietary supplement: Low-oxalate fixed diet

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 Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
estimated endogenous oxalate synthesis rate	Average fasted hourly urinary oxalate excretion rate normalized to urinary creatinine excretion (mg oxalate / g urinary creatinine)	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Oxalate excretion	average urinary oxalate excretion rate normalized to urinary creatinine after equilibration on a low-oxalate fixed diet (mg urinary oxalate / g urinary creatinine)	2 days

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Kyle D Wood, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: oxalate metabolism; MASLD; oxalate synthesis
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: IRB300002318-FLO; UAB (Other Identifier: UAB); 1R03DK139235-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No