GLP-1 RA on Liver OMICS in MASLD

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorMedical College of Wisconsin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

known diagnosis of MASLD by histology, also have diabetes/ obesity

on treatment with GLP-1 RA at stable dose

Disqualifiers

unable to have a liver biopsy, recent change in medication for diabetes or hyperlipidemia

on immunosuppression, liver or kidney transplant

pregnancy

Trial population

known diagnosis of MASLD by histology, also have diabetes/ obesity

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • GLP-1 receptor agonist

    Drug

    on and not on treatment

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Without GLP-1 RA treatment0 interventions
Group B: Had GLP-1 RA treatment1 intervention

Trial outcomes

Primary outcomes

1

Changes in lipidomics profile on use of GLP-1 RA

Lipidomic profile being evaluated

Time frame
1 year

Secondary outcomes

1

Changes in associated proteomics and transcriptomics with the use of GLP-1 RA

proteomic and transcriptomics profiles evaluated

Time frame
1 year

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: