Influence of Metabolic Syndrome on Endogenous Oxalate Synthesis

NCT06735924 | Recruiting

• 3 other identifiers: IRB300002318-FLO1R03DK139235-01UAB
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

MASLD; Metabolic Dysfunction-Associated Steatotic Liver Disease

Keywords

oxalate synthesis; oxalate metabolism; MASLD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Urinary Oxalate excretion

  2 days

Study Arms (1)

Estimation of endogenous oxalate production

EXPERIMENTAL

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

Dietary Supplement: Low-oxalate fixed diet

Interventions

Low-oxalate fixed diet DIETARY_SUPPLEMENT

Ingestion of a low-oxalate (\< 60 mg/day) , normal calcium (800-1200 mg/d) eucaloric diet for 5 days

Estimation of endogenous oxalate production

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

Study Officials

• Kyle D Wood, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyle D Wood, MD

CONTACT

2059968765; kylewood@uabmc.edu

Sonia Fargue, PhD

CONTACT

2059756932; sfargue@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: April 26, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)