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Completed

NCT Number: NCT03986684

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

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)

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Key information

Conditions

Nonalcoholic Fatty Liver Digestive System Diseases Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases Metabolic Syndrome Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hippokration General Hospital

Thessaloniki, 54642, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Proglucagon-derived hormones

    Time frame: baseline

    glucagon-like peptide GLP-1 (pg/ml)

  2. Proglucagon-derived hormones

    Time frame: baseline

    glucagon-like peptide GLP-2 (pg/ml)

  3. Proglucagon-derived hormones

    Time frame: baseline

    glicentin (pmol/l)

  4. Proglucagon-derived hormones

    Time frame: baseline

    oxyntomodulin (pg/ml)

  5. Proglucagon-derived hormones

    Time frame: baseline

    glucagon (pg/ml)

  6. Proglucagon-derived hormones

    Time frame: baseline

    major proglucagon fragment [MPGF]) (ng/ml)

  7. Follistatins-activins

    Time frame: baseline

    follistatin-like (FSTL)3 (ng/ml)

  8. Follistatins-activins

    Time frame: baseline

    activin B (pg/ml)

  9. IGF axis

    Time frame: baseline

    insulin-like growth factor (IGF)-1 (ng/ml)

  10. IGF axis

    Time frame: baseline

    total and intact IGF binding protein (IGFBP)-3 and IGFBP-4 (ng/ml)

  11. Liver ultrasound

    Time frame: baseline

    Estimation of echogenicity, hepatomegaly, and intra-hepatic vascular blurring (1: Intermediate, 1-2: Intermediate to Moderate, 2: Moderate, 3: Severe)

  12. GDF-15

    Time frame: baseline

    Total and intact Growth differentiation factor 15 (pg/mL)

Secondary outcomes

  1. Body Mass Index (BMI)

    Time frame: baseline

    BMI is calculated as weight in kilograms divided by height in meters squared.

  2. Biochemical parameters

    Time frame: baseline

    Glucose (mg/dl)

  3. Biochemical parameters

    Time frame: baseline

    serum aspartate transaminase (AST) (U/L), ALT (U/L)

  4. Biochemical parameters

    Time frame: baseline

    gamma-glutamyltransferase (GGT) (U/L)

  5. Biochemical parameters

    Time frame: baseline

    total cholesterol (mg/dl), triglycerides (mg/dl) and high density lipoprotein-cholesterol (HDL-C) (mg/dl), low density lipoprotein-cholesterol (LDL-C) (mg/dl)

  6. Biochemical parameters

    Time frame: baseline

    insulin (μU/ml)

  7. Metabolomics and lipidomics analysis

    Time frame: baseline

    Measured with nuclear magnetic resonance spectroscopy (NMR) by Labcorp (Morrisville, USA).

Sponsors and collaborators

Lead sponsor

Hippocration General Hospital

Other

Registry information

Official study title

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

Acronym: NAFLD

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 14, 2019
Registry last updated
Dec 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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