Effect of Glucagon-like Peptide -1 Receptor Agonist on Liver Tissue and Plasma Lipids in MASLD
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in lipidomics profile on use of GLP-1 RA
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •known diagnosis of MASLD by histology, also have diabetes/ obesity
- •on treatment with GLP-1 RA at stable dose
排除标准
- •unable to have a liver biopsy, recent change in medication for diabetes or hyperlipidemia
- •on immunosuppression, liver or kidney transplant
- •pregnancy
研究组 & 干预措施
Had GLP-1 RA treatment
Patients with MASLD and obesity/diabetes - on GLP-1 RA as a standard of care treatment
干预措施: GLP-1 receptor agonist (Drug)
Without GLP-1 RA treatment
Patients with MASLD and obesity/diabetes - on standard of care treatment but not on any GLP-1 RA
结局指标
主要结局
Changes in lipidomics profile on use of GLP-1 RA
时间窗: 1 year
Lipidomic profile being evaluated
Changes in lipidomics profile on use of GLP-1 RA
时间窗: 1 year
Lipidomic profile being evaluated
次要结局
- Changes in associated proteomics and transcriptomics with the use of GLP-1 RA(1 year)
- Changes in associated proteomics and transcriptomics with the use of GLP-1 RA(1 year)
研究者
Achuthan Sourianarayanane
Associate Professor
Medical College of Wisconsin