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CompletedNCT03986684NAFLDUpdated Dec 27, 2022

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

An observational study in Nonalcoholic Fatty Liver and Metabolic Syndrome, sponsored by Hippocration General Hospital. Completed at 1 site in Greece. Per ClinicalTrials.gov, last updated 2022-12-27.

Sponsored by Hippocration General Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
32
Sex
All
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Study 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)

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Conditions studied

  • Nonalcoholic Fatty Liver
  • Metabolic Syndrome
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In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 32 is below the median of 167 across 681 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Hippocration General Hospital is the lead sponsor of 27 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Subjects from the Second Propaedeutic Department of Internal Medicine, Ippokration Hospital, Aristotle University of Thessaloniki, Greece

Inclusion criteria

  • Individuals with liver ultrasound imaging
  • Adults

Exclusion criteria

Exclusion Criteria:

  • The presence of any secondary cause of fatty liver, such as viral, alcoholic, autoimmune and drug-induced hepatitis.
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
32 participants (actual)
Patient registry
No

Groups and cohorts

  • Non-NAFLD
  • NAFLD
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What researchers measure

Primary outcomes

  1. Proglucagon-derived hormones

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

    Time frame: baseline

  2. Proglucagon-derived hormones

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

    Time frame: baseline

  3. Proglucagon-derived hormones

    glicentin (pmol/l)

    Time frame: baseline

  4. Proglucagon-derived hormones

    oxyntomodulin (pg/ml)

    Time frame: baseline

  5. Proglucagon-derived hormones

    glucagon (pg/ml)

    Time frame: baseline

  6. Proglucagon-derived hormones

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

    Time frame: baseline

  7. Follistatins-activins

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

    Time frame: baseline

  8. Follistatins-activins

    activin B (pg/ml)

    Time frame: baseline

  9. IGF axis

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

    Time frame: baseline

  10. IGF axis

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

    Time frame: baseline

  11. Liver ultrasound

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

    Time frame: baseline

  12. GDF-15

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

    Time frame: baseline

Secondary outcomes

  1. Body Mass Index (BMI)

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

    Time frame: baseline

  2. Biochemical parameters

    Glucose (mg/dl)

    Time frame: baseline

  3. Biochemical parameters

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

    Time frame: baseline

  4. Biochemical parameters

    gamma-glutamyltransferase (GGT) (U/L)

    Time frame: baseline

  5. 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)

    Time frame: baseline

  6. Biochemical parameters

    insulin (μU/ml)

    Time frame: baseline

  7. Metabolomics and lipidomics analysis

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

    Time frame: baseline

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Study locations

1 site
  • Hippokration General Hospital
    Thessaloniki, 54642, Greece
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References and documents

Publications

  • Polyzos SA, Perakakis N, Boutari C, Kountouras J, Ghaly W, Anastasilakis AD, Karagiannis A, Mantzoros CS. Targeted Analysis of Three Hormonal Systems Identifies Molecules Associated with the Presence and Severity of NAFLD. J Clin Endocrinol Metab. 2020 Mar 1;105(3):e390-400. doi: 10.1210/clinem/dgz172. PubMed 31690932 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03986684
Lead sponsor
Hippocration General Hospital
Responsible party
Chrysoula Boutari (Clinical Fellow, Second Propedeutic Department of Internal Medicine, MD, MSc, PhD, Hippocration General Hospital) — Principal investigator
First posted
Jun 14, 2019
Start date
Jan 5, 2017
Primary completion
May 30, 2017
Completion
May 30, 2017
Last update
Dec 27, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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