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

Completed

• Conditions: Nonalcoholic Fatty Liver; Metabolic Syndrome

• Registration Number: NCT03986684
• Lead Sponsor: Hippocration General Hospital

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-05
• Primary Completion: 2017-05-30
• Study Completion: 2017-05-30
• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-13
• Study First Posted: 2019-06-14
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-22
• Last Update Posted: 2022-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Follistatins-activins	baseline	activin B (pg/ml)
IGF axis	baseline	total and intact IGF binding protein (IGFBP)-3 and IGFBP-4 (ng/ml)
GDF-15	baseline	Total and intact Growth differentiation factor 15 (pg/mL)
Liver ultrasound	baseline	Estimation of echogenicity, hepatomegaly, and intra-hepatic vascular blurring (1: Intermediate, 1-2: Intermediate to Moderate, 2: Moderate, 3: Severe)
Proglucagon-derived hormones	baseline	major proglucagon fragment \[MPGF\]) (ng/ml)

Secondary Outcome Measures

Name	Time	Method
Body Mass Index (BMI)	baseline	BMI is calculated as weight in kilograms divided by height in meters squared.
Biochemical parameters	baseline	insulin (μU/ml)
Metabolomics and lipidomics analysis	baseline	Measured with nuclear magnetic resonance spectroscopy (NMR) by Labcorp (Morrisville, USA).

Trial Locations

Locations (1)

Hippokration General Hospital; 🇬🇷 Thessaloniki, Greece