Molecules Associated With the Presence and Severity of Nonalcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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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)

Official Title
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Targeted Analysis of Three Hormonal Systems Identifies Molecules Associated With the Presence and Severity of Nonalcoholic Fatty Liver Disease

Conditions
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Nonalcoholic Fatty Liver, Metabolic Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals with liver ultrasound imaging Adults Exclusion Criteria: The presence of any secondary cause of fatty liver, such as viral, alcoholic, autoimmune and drug-induced hepatitis.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-NAFLD<br> | |
| NAFLD<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proglucagon-derived hormones | glucagon-like peptide GLP-1 (pg/ml) | baseline | 
| Proglucagon-derived hormones | glucagon-like peptide GLP-2 (pg/ml) | baseline | 
| Proglucagon-derived hormones | glicentin (pmol/l) | baseline | 
| Proglucagon-derived hormones | oxyntomodulin (pg/ml) | baseline | 
| Proglucagon-derived hormones | glucagon (pg/ml) | baseline | 
| Proglucagon-derived hormones | major proglucagon fragment [MPGF]) (ng/ml) | baseline | 
| Follistatins-activins | follistatin-like (FSTL)3 (ng/ml) | baseline | 
| Follistatins-activins | activin B (pg/ml) | baseline | 
| IGF axis | insulin-like growth factor (IGF)-1 (ng/ml) | baseline | 
| IGF axis | total and intact IGF binding protein (IGFBP)-3 and IGFBP-4 (ng/ml) | baseline | 
| Liver ultrasound | Estimation of echogenicity, hepatomegaly, and intra-hepatic vascular blurring (1: Intermediate, 1-2: Intermediate to Moderate, 2: Moderate, 3: Severe) | baseline | 
| GDF-15 | Total and intact Growth differentiation factor 15 (pg/mL) | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) | BMI is calculated as weight in kilograms divided by height in meters squared. | baseline | 
| Biochemical parameters | Glucose (mg/dl) | baseline | 
| Biochemical parameters | serum aspartate transaminase (AST) (U/L), ALT (U/L) | baseline | 
| Biochemical parameters | gamma-glutamyltransferase (GGT) (U/L) | baseline | 
| Biochemical parameters | total cholesterol (mg/dl), triglycerides (mg/dl) and high density lipoprotein-cholesterol (HDL-C) (mg/dl), low density lipoprotein-cholesterol (LDL-C) (mg/dl) | baseline | 
| Biochemical parameters | insulin (μU/ml) | baseline | 
| Metabolomics and lipidomics analysis | Measured with nuclear magnetic resonance spectroscopy (NMR) by Labcorp (Morrisville, USA). | baseline |