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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03986684

Acronym

NAFLD

Enrollment

Registered

2019-06-14

Start date

2017-01-05

Completion date

2017-05-30

Last updated

2022-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, Nonalcoholic Fatty Liver

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)

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
GDF-15	baseline	Total and intact Growth differentiation factor 15 (pg/mL)
Follistatins-activins	baseline	follistatin-like (FSTL)3 (ng/ml)
IGF axis	baseline	insulin-like growth factor (IGF)-1 (ng/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	glucagon-like peptide GLP-1 (pg/ml)

Secondary

Measure	Time frame	Description
Biochemical parameters	baseline	Glucose (mg/dl)
Metabolomics and lipidomics analysis	baseline	Measured with nuclear magnetic resonance spectroscopy (NMR) by Labcorp (Morrisville, USA).
Body Mass Index (BMI)	baseline	BMI is calculated as weight in kilograms divided by height in meters squared.

Countries

Greece

Outcome results