NCT03986684

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 14, 2019

Completed
Last Updated

December 27, 2022

Status Verified

December 1, 2022

Enrollment Period

5 months

First QC Date

June 7, 2019

Last Update Submit

December 22, 2022

Conditions

Nonalcoholic Fatty LiverMetabolic Syndrome

Outcome Measures

Primary Outcomes (12)

  • Proglucagon-derived hormones

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

    baseline

  • Proglucagon-derived hormones

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

    baseline

  • Proglucagon-derived hormones

    glicentin (pmol/l)

    baseline

  • Proglucagon-derived hormones

    oxyntomodulin (pg/ml)

    baseline

  • Proglucagon-derived hormones

    glucagon (pg/ml)

    baseline

  • Proglucagon-derived hormones

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

    baseline

  • Follistatins-activins

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

    baseline

  • Follistatins-activins

    activin B (pg/ml)

    baseline

  • IGF axis

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

    baseline

  • IGF axis

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

    baseline

  • Liver ultrasound

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

    baseline

  • GDF-15

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

    baseline

Secondary Outcomes (7)

  • Body Mass Index (BMI)

    baseline

  • Biochemical parameters

    baseline

  • Biochemical parameters

    baseline

  • Biochemical parameters

    baseline

  • Biochemical parameters

    baseline

  • +2 more secondary outcomes

Study Arms (2)

Non-NAFLD

NAFLD

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Individuals with liver ultrasound imaging
  • Adults

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hippokration General Hospital

Thessaloniki, 54642, Greece

Location

Related Publications (2)

  • Boutari C, Stefanakis K, Simati S, Guatibonza-Garcia V, Valenzuela-Vallejo L, Anastasiou IA, Connelly MA, Kokkinos A, Mantzoros CS. Circulating total and H-specific GDF15 levels are elevated in subjects with MASLD but not in hyperlipidemic but otherwise metabolically healthy subjects with obesity. Cardiovasc Diabetol. 2024 May 18;23(1):174. doi: 10.1186/s12933-024-02264-5.

    PMID: 38762719DERIVED

  • 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.

    PMID: 31690932DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseMetabolic Syndrome

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Fellow, Second Propedeutic Department of Internal Medicine, MD, MSc, PhD

Study Record Dates

First Submitted

June 7, 2019

First Posted

June 14, 2019

Study Start

January 5, 2017

Primary Completion

May 30, 2017

Study Completion

May 30, 2017

Last Updated

December 27, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)