Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03986684
Recruitment Status : Completed
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Chrysoula Boutari, Hippocration General Hospital

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


Condition or disease
Nonalcoholic Fatty Liver Metabolic Syndrome

Layout table for study information
Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Targeted Analysis of Three Hormonal Systems Identifies Molecules Associated With the Presence and Severity of Nonalcoholic Fatty Liver Disease
Actual Study Start Date : January 5, 2017
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : May 30, 2017


Group/Cohort
Non-NAFLD
NAFLD



Primary Outcome Measures :
  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)


Secondary Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986684


Locations
Layout table for location information
Greece
Hippokration General Hospital
Thessaloniki, Greece, 54642
Sponsors and Collaborators
Hippocration General Hospital

Layout table for additonal information
Responsible Party: Chrysoula Boutari, Clinical Fellow, Second Propedeutic Department of Internal Medicine, MD, MSc, PhD, Hippocration General Hospital
ClinicalTrials.gov Identifier: NCT03986684     History of Changes
Other Study ID Numbers: Hippocratio_2017
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Syndrome
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases