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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03986684
Other study ID # Hippocratio_2017
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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