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NCT Number: NCT06735924

Influence of Metabolic Syndrome on 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. estimated endogenous oxalate synthesis rate

    Time frame: 1 day

    Average fasted hourly urinary oxalate excretion rate normalized to urinary creatinine excretion (mg oxalate / g urinary creatinine)

Secondary outcomes

  1. Urinary Oxalate excretion

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Non Alcoholic Fatty Liver Disease and Endogenous Oxalate Synthesis

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 16, 2024
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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