Targeted Analysis of Three Hormonal Systems Identifies Molecules Associated With the Presence and Severity of Nonalcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Follistatins-activins
研究概览
简要总结
Non-invasive diagnosis and treatment of nonalcoholic fatty liver disease (NAFLD) remain unmet medical needs. Aim of this study is to investigate the blood levels of three hormonal systems related to obesity, insulin resistance and inflammation in patients with different stages of NAFLD, in order to identify potential diagnostic markers.
Study aim: To compare the blood levels of: a) proglucagon-derived hormones (glucagon-like peptide [GLP]-1, GLP-2, glicentin, oxyntomodulin, glucagon, major proglucagon fragment [MPGF]), b) follistatins-activins (follistatin-like (FSTL)3, activin B), c) IGF axis (insulin-like growth factor (IGF)-1, total and intact IGF binding protein (IGFBP)-3 and IGFBP-4, in 18 individuals with early stage NAFLD vs. 14 controls To explore the levels of GDF-15, total and intact, in NAFLD versus obese controls (OC) at baseline and during oral glucose tolerance tests (OGTTs)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals with liver ultrasound imaging
排除标准
- •The presence of any secondary cause of fatty liver, such as viral, alcoholic, autoimmune and drug-induced hepatitis.
结局指标
主要结局
Follistatins-activins
时间窗: baseline
activin B (pg/ml)
IGF axis
时间窗: baseline
total and intact IGF binding protein (IGFBP)-3 and IGFBP-4 (ng/ml)
GDF-15
时间窗: baseline
Total and intact Growth differentiation factor 15 (pg/mL)
Liver ultrasound
时间窗: baseline
Estimation of echogenicity, hepatomegaly, and intra-hepatic vascular blurring (1: Intermediate, 1-2: Intermediate to Moderate, 2: Moderate, 3: Severe)
Proglucagon-derived hormones
时间窗: baseline
major proglucagon fragment \[MPGF\]) (ng/ml)
次要结局
- Body Mass Index (BMI)(baseline)
- Biochemical parameters(baseline)
- Metabolomics and lipidomics analysis(baseline)
研究者
Chrysoula Boutari
Clinical Fellow, Second Propedeutic Department of Internal Medicine, MD, MSc, PhD
Hippocration General Hospital