GLP-1 RA on Liver OMICS in MASLD

NCT ID: NCT06982378

Last Updated: 2025-10-14

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

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-12-31

Brief Summary

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In patients with type II diabetes mellitus (T2DM) and obesity, an excess plasma-free fatty acid is found with an associated increased lipid accumulation in adipocytes and liver tissue. Lipid droplet accumulation in the hepatocytes is an initial step in the development of metabolic dysfunction associated steatotic liver disease (MASLD. Insulin resistance, which is associated with T2DM, mediates the inflammation of these lipids, resulting in the progression of MASLD to metabolic dysfunction associated steatotic hepatitis (MASH). Hence, in T2DM, obesity, and MASLD, changes in the lipid profile occur, and they are interrelated.

In this study, we aim to assess improvement in the lipidomic, its associated metabolic changes and evaluate the co-regulated genes in the liver tissue among patients with MASLD with intervention with GLP-1 RA, which has shown to benefit T2DM and obesity.

Detailed Description

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The study involves patients with a diagnosis of MASLD by histology and have diabetes/obesity. The 'omics' ( lipidomics, proteomics, metabolites, and inflammatory profiles and transcriptomics) data of liver tissue and plasma of patients will be compared between patients who have received 1 year of GLP-1 treatment with those who did not have GLP-1 agents.

The study will evaluate the changes in different 'omics' and metabolites in the liver tissue following the use of GLP-1 agents in these patients

Conditions

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NAFLD Diabetes Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Without GLP-1 RA treatment

Patients with MASLD and obesity/diabetes - on standard of care treatment but not on any GLP-1 RA

No interventions assigned to this group

Had GLP-1 RA treatment

Patients with MASLD and obesity/diabetes - on GLP-1 RA as a standard of care treatment

GLP-1 receptor agonist

Intervention Type DRUG

on and not on treatment

Interventions

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GLP-1 receptor agonist

on and not on treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* known diagnosis of MASLD by histology, also have diabetes/ obesity
* on treatment with GLP-1 RA at stable dose

Exclusion Criteria

* unable to have a liver biopsy, recent change in medication for diabetes or hyperlipidemia
* on immunosuppression, liver or kidney transplant
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Achuthan Sourianarayanane

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Froedtert Hospital

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Central Contacts

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Achuthan Sourianarayanane, MD

Role: CONTACT

4149556850

Other Identifiers

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PRO00050604

Identifier Type: -

Identifier Source: org_study_id

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