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Clinical Trial NCT06982378 (OMICS in MASLD) for NAFLD, Diabetes, Obesity is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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GLP-1 RA on Liver OMICS in MASLD 30
Clinical Trial NCT06982378 (OMICS in MASLD) is an observational study for NAFLD, Diabetes, Obesity and is currently not yet recruiting. Enrollment is planned to begin on July 1, 2026 and continue until the study accrues 30 participants. Led by Medical College of Wisconsin, this study is expected to complete by December 1, 2028. The latest data from ClinicalTrials.gov was last updated on March 10, 2026.
Brief Summary
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 the...Show More
Detailed Description
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 me...
Show MoreOfficial Title
Effect of Glucagon-like Peptide -1 Receptor Agonist on Liver Tissue and Plasma Lipids in MASLD
Conditions
NAFLDDiabetesObesityOther Study IDs
- OMICS in MASLD
- PRO00050604
NCT ID Number
Start Date (Actual)
2026-07
Last Update Posted
2026-03-10
Completion Date (Estimated)
2028-12
Enrollment (Estimated)
30
Study Type
Observational
Status
Not yet recruiting
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Without GLP-1 RA treatment Patients with MASLD and obesity/diabetes - on standard of care treatment but not on any GLP-1 RA | N/A |
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 on and not on treatment |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Changes in lipidomics profile on use of GLP-1 RA | Lipidomic profile being evaluated | 1 year |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Changes in associated proteomics and transcriptomics with the use of GLP-1 RA | proteomic and transcriptomics profiles evaluated | 1 year |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- known diagnosis of MASLD by histology, also have diabetes/ obesity
- on treatment with GLP-1 RA at stable dose
- unable to have a liver biopsy, recent change in medication for diabetes or hyperlipidemia
- on immunosuppression, liver or kidney transplant
- pregnancy
Study Responsible Party
Achuthan Sourianarayanane, Principal Investigator, Associate Professor, Medical College of Wisconsin
Study Central Contact
Contact: Achuthan Sourianarayanane, MD, 4149556850, [email protected]
1 Study Locations in 1 Countries
Wisconsin
Froedtert Hospital, Milwaukee, Wisconsin, 53226, United States