Clinical trial NCT03986684: Molecules Associated With the Presence and Severity of Nonalcoholic Fatty Liver Disease
Official title: Targeted Analysis of Three Hormonal Systems Identifies Molecules Associated With the Presence and Severity of Nonalcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonalcoholic Fatty Liver
Metabolic Syndrome
Lead sponsor: Hippocration General Hospital
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects from the Second Propaedeutic Department of Internal Medicine, Ippokration Hospital, Aristotle University of Thessaloniki, Greece

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)


Eligibility 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.

Primary outcomes:
measure: Proglucagon-derived hormones
timeFrame: baseline
measure: Proglucagon-derived hormones
timeFrame: baseline
measure: Proglucagon-derived hormones
timeFrame: baseline
measure: Proglucagon-derived hormones
timeFrame: baseline
measure: Proglucagon-derived hormones
timeFrame: baseline
measure: Proglucagon-derived hormones
timeFrame: baseline
measure: Follistatins-activins
timeFrame: baseline
measure: Follistatins-activins
timeFrame: baseline
measure: IGF axis
timeFrame: baseline
measure: IGF axis
timeFrame: baseline
measure: Liver ultrasound
timeFrame: baseline
measure: GDF-15
timeFrame: baseline
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: baseline
measure: Biochemical parameters
timeFrame: baseline
measure: Biochemical parameters
timeFrame: baseline
measure: Biochemical parameters
timeFrame: baseline
measure: Biochemical parameters
timeFrame: baseline
measure: Biochemical parameters
timeFrame: baseline
measure: Metabolomics and lipidomics analysis
timeFrame: baseline
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Hippokration General Hospital
Study officials:
References:
citation: 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.