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Influence of Metabolic Syndrome on Endogenous Oxalate Synthesis

NCT ID: NCT06735924

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-26

Study Completion Date

2027-12-31

Brief Summary

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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

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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).

Conditions

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MASLD Metabolic Dysfunction-Associated Steatotic Liver Disease

Keywords

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MASLD oxalate synthesis oxalate metabolism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Estimation of endogenous oxalate production

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

Group Type EXPERIMENTAL

Low-oxalate fixed diet

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Low-oxalate fixed diet

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Kyle D. Wood

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyle D Wood, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kyle D Wood, MD

Role: CONTACT

Phone: 2059968765

Email: [email protected]

Sonia Fargue, PhD

Role: CONTACT

Phone: 2059756932

Email: [email protected]

Facility Contacts

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Study Coordinator, MS

Role: primary

Other Identifiers

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1R03DK139235-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UAB

Identifier Type: OTHER

Identifier Source: secondary_id

IRB300002318-FLO

Identifier Type: -

Identifier Source: org_study_id