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

Metabolic Syndrome Clinical Trial

— NAFLD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03986684
• Other study ID #: Hippocratio_2017
• Status: Completed
• Start date: January 5, 2017
• Est. completion date: May 30, 2017

Study information

• Verified date: December 2022
• Source: Hippocration General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 30, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Metabolic Syndrome
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver

Locations

Country	Name	City	State
Greece	Hippokration General Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Hippocration General Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proglucagon-derived hormones	glucagon-like peptide GLP-1 (pg/ml)	baseline
Primary	Proglucagon-derived hormones	glucagon-like peptide GLP-2 (pg/ml)	baseline
Primary	Proglucagon-derived hormones	glicentin (pmol/l)	baseline
Primary	Proglucagon-derived hormones	oxyntomodulin (pg/ml)	baseline
Primary	Proglucagon-derived hormones	glucagon (pg/ml)	baseline
Primary	Proglucagon-derived hormones	major proglucagon fragment [MPGF]) (ng/ml)	baseline
Primary	Follistatins-activins	follistatin-like (FSTL)3 (ng/ml)	baseline
Primary	Follistatins-activins	activin B (pg/ml)	baseline
Primary	IGF axis	insulin-like growth factor (IGF)-1 (ng/ml)	baseline
Primary	IGF axis	total and intact IGF binding protein (IGFBP)-3 and IGFBP-4 (ng/ml)	baseline
Primary	Liver ultrasound	Estimation of echogenicity, hepatomegaly, and intra-hepatic vascular blurring (1: Intermediate, 1-2: Intermediate to Moderate, 2: Moderate, 3: Severe)	baseline
Primary	GDF-15	Total and intact Growth differentiation factor 15 (pg/mL)	baseline
Secondary	Body Mass Index (BMI)	BMI is calculated as weight in kilograms divided by height in meters squared.	baseline
Secondary	Biochemical parameters	Glucose (mg/dl)	baseline
Secondary	Biochemical parameters	serum aspartate transaminase (AST) (U/L), ALT (U/L)	baseline
Secondary	Biochemical parameters	gamma-glutamyltransferase (GGT) (U/L)	baseline
Secondary	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
Secondary	Biochemical parameters	insulin (µU/ml)	baseline
Secondary	Metabolomics and lipidomics analysis	Measured with nuclear magnetic resonance spectroscopy (NMR) by Labcorp (Morrisville, USA).	baseline