Nonalcoholic Fatty LiverNAFLDNCT03986684
Molecules Associated With the Presence and Severity of Nonalcoholic Fatty Liver Disease
An observational study of Nonalcoholic Fatty Liver and Metabolic Syndrome, run by Hippocration General Hospital at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nonalcoholic Fatty Liver, Metabolic Syndrome
- How many people
- 32 participants
- Where
- 1 siteGreece
- Study dates
- 5 Jan 2017to 30 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects from the Second Propaedeutic Department of Internal Medicine, Ippokration Hospital, Aristotle University of Thessaloniki, Greece
Who may be able to join
- Individuals with liver ultrasound imaging
- Adults
Who cannot join
- The presence of any secondary cause of fatty liver, such as viral, alcoholic, autoimmune and drug-induced hepatitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeted Analysis of Three Hormonal Systems Identifies 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)
- Conditions
- Nonalcoholic Fatty Liver, Metabolic Syndrome
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-NAFLD | Not described | |
| NAFLD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proglucagon-derived hormones
glucagon-like peptide GLP-1 (pg/ml)
Measured: baseline
Proglucagon-derived hormones
glucagon-like peptide GLP-2 (pg/ml)
Measured: baseline
Proglucagon-derived hormones
glicentin (pmol/l)
Measured: baseline
Proglucagon-derived hormones
oxyntomodulin (pg/ml)
Measured: baseline
Proglucagon-derived hormones
glucagon (pg/ml)
Measured: baseline
Proglucagon-derived hormones
major proglucagon fragment [MPGF]) (ng/ml)
Measured: baseline
Follistatins-activins
follistatin-like (FSTL)3 (ng/ml)
Measured: baseline
Follistatins-activins
activin B (pg/ml)
Measured: baseline
IGF axis
insulin-like growth factor (IGF)-1 (ng/ml)
Measured: baseline
IGF axis
total and intact IGF binding protein (IGFBP)-3 and IGFBP-4 (ng/ml)
Measured: baseline
Liver ultrasound
Estimation of echogenicity, hepatomegaly, and intra-hepatic vascular blurring (1: Intermediate, 1-2: Intermediate to Moderate, 2: Moderate, 3: Severe)
Measured: baseline
GDF-15
Total and intact Growth differentiation factor 15 (pg/mL)
Measured: baseline
Secondary outcomes (7)
Body Mass Index (BMI)
BMI is calculated as weight in kilograms divided by height in meters squared.
Measured: baseline
Biochemical parameters
Glucose (mg/dl)
Measured: baseline
Biochemical parameters
serum aspartate transaminase (AST) (U/L), ALT (U/L)
Measured: baseline
Biochemical parameters
gamma-glutamyltransferase (GGT) (U/L)
Measured: baseline
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)
Measured: baseline
Biochemical parameters
insulin (μU/ml)
Measured: baseline
Metabolomics and lipidomics analysis
Measured with nuclear magnetic resonance spectroscopy (NMR) by Labcorp (Morrisville, USA).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start5 Jan 2017
- Primary completion30 May 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nonalcoholic Fatty LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hippocration General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chrysoula Boutari, Hippocration General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986684
- Sponsor's protocol ID
- Hippocratio_2017
- Acronym
- NAFLD
- Status last verified
- Dec 2022
- First submitted
- 7 Jun 2019
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38762719Polyzos 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Analysis of Three Hormonal Systems Identifies Molecules Associated With the Presence and Severity of Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT03986684
- Acronym / sponsor ID
- NAFLD / Hippocratio_2017
- Conditions
- Nonalcoholic Fatty Liver, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hippocration General HospitalUniversity, hospital or other
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-NAFLD | – | – |
| NAFLD | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects from the Second Propaedeutic Department of Internal Medicine, Ippokration Hospital, Aristotle University of Thessaloniki, Greece
Key inclusion criteria (2 listed)
- Individuals with liver ultrasound imaging
- Adults
Key exclusion criteria (1 listed)
- The presence of any secondary cause of fatty liver, such as viral, alcoholic, autoimmune and drug-induced hepatitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proglucagon-derived hormones
Time frame: baseline
glucagon-like peptide GLP-1 (pg/ml)
Proglucagon-derived hormones
Time frame: baseline
glucagon-like peptide GLP-2 (pg/ml)
Proglucagon-derived hormones
Time frame: baseline
glicentin (pmol/l)
Proglucagon-derived hormones
Time frame: baseline
oxyntomodulin (pg/ml)
Proglucagon-derived hormones
Time frame: baseline
glucagon (pg/ml)
Proglucagon-derived hormones
Time frame: baseline
major proglucagon fragment [MPGF]) (ng/ml)
Follistatins-activins
Time frame: baseline
follistatin-like (FSTL)3 (ng/ml)
Follistatins-activins
Time frame: baseline
activin B (pg/ml)
IGF axis
Time frame: baseline
insulin-like growth factor (IGF)-1 (ng/ml)
IGF axis
Time frame: baseline
total and intact IGF binding protein (IGFBP)-3 and IGFBP-4 (ng/ml)
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)
GDF-15
Time frame: baseline
Total and intact Growth differentiation factor 15 (pg/mL)
7 secondary outcomes
Body Mass Index (BMI)
Time frame: baseline
Biochemical parameters
Time frame: baseline
Biochemical parameters
Time frame: baseline
Biochemical parameters
Time frame: baseline
Biochemical parameters
Time frame: baseline
Biochemical parameters
Time frame: baseline
Metabolomics and lipidomics analysis
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Derived from this study: PubMed 38762719Boutari 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.
- Derived from this study: PubMed 31690932Polyzos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonalcoholic Fatty Liver and Metabolic Syndrome, run by Hippocration General Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proglucagon-derived hormones (time frame: baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03986684, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2022; AzTrials last refreshed its copy on 7 Nov 2026.