Non-alcoholic Fatty Liver DiseaseNCT01472120
Adiponectin and Circulating Macrophage Phenotypes in Non-alcoholic Fatty Liver Disease (NAFLD)
An observational study of Non-alcoholic Fatty Liver Disease, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
In peripheral blood; monocytes and macrophages are found in two phenotype; proinflammatory M1 and anti-inflammatory M2 phenotypes. M2 form is converted (or polarized) to M1 phenotype in various metabolic disorders such as obesity and type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2011to Jan 2013
- 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 20 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: A sample of male outpatients with histologically proven NAFLD, who attended the outpatient clinic of the Gastroenterology Department, Gulhane School of Medicine, Ankara, Turkey
Who may be able to join
- Persistently (at least 6 months) elevated aminotransferases
- Ultrasonographic presence of bright liver without any other liver or biliary tract disease
- Liver histology compatible with a diagnosis of NASH or SS
Who cannot join
- A history of alcohol consumption >40 g/wk, as assessed by a detailed interview extended to family members
- Morbid obesity [body mass index (BMI) ≥40 kg/m2], hypertension
- Positive blood markers of viral, autoimmune, or celiac disease
- Abnormal copper metabolism or thyroid function tests
- A diagnosis of T2DM and systemic arterial hypertension
- Total cholesterol (TC) ≥250 mg/dL, triglycerides (TG) ≥400 mg/dL, exposure to occupational hepatotoxins or drugs known to affect glucose and lipid metabolism
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gastroenterology Department, Gulhane School of Medicine
Ankara, 06018
About this study
Official title: The Relationship of Adiponectin With Circulating Macrophage Phenotypes in Non-alcoholic Fatty Liver Disease
In peripheral blood; monocytes and macrophages are found in two phenotype; proinflammatory M1 and anti-inflammatory M2 phenotypes. M2 form is converted (or polarized) to M1 phenotype in various metabolic disorders such as obesity and type 2 diabetes mellitus.
Read the detailed description
In peripheral blood; monocytes and macrophages are found in two phenotype; proinflammatory M1 and anti-inflammatory M2 phenotypes.
M2 form is converted (or polarized) to M1 phenotype in various metabolic disorders such as obesity and type 2 diabetes mellitus. In addition, these forms also are related to insulin resistance and inflammation in adipose tissue.
Today, there is no study that investigate the role of adiponectin an anti-inflammatory adipokine, on macrophage polarization in non-alcoholic fatty liver disease.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
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 |
|---|---|---|
| P and C | P: NAFLD patients C: Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
For laboratory analyses, the collection of all blood samples from the study participants.
Measured: Collection of blood samples in one year and analyses of data in 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionSep 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Genc, Gulhane School of Medicine
- Investigators
- halil genc, MD, Principal investigator, Gulhane Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472120
- Sponsor's protocol ID
- NASH-macrophage
- Status last verified
- Aug 2011
- First submitted
- 11 Aug 2011
- Last updated
- 16 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Adiponectin With Circulating Macrophage Phenotypes in Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT01472120
- Acronym / sponsor ID
- NASH-macrophage
- Conditions
- Non-alcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 16 Nov 2011 (estimated)
- 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.
In peripheral blood; monocytes and macrophages are found in two phenotype; proinflammatory M1 and anti-inflammatory M2 phenotypes. M2 form is converted (or polarized) to M1 phenotype in various metabolic disorders such as obesity and type 2 diabetes mellitus.
Detailed description
In peripheral blood; monocytes and macrophages are found in two phenotype; proinflammatory M1 and anti-inflammatory M2 phenotypes.
M2 form is converted (or polarized) to M1 phenotype in various metabolic disorders such as obesity and type 2 diabetes mellitus. In addition, these forms also are related to insulin resistance and inflammation in adipose tissue.
Today, there is no study that investigate the role of adiponectin an anti-inflammatory adipokine, on macrophage polarization in non-alcoholic fatty liver disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| P and C | – | –P: NAFLD patients C: Healthy controls |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A sample of male outpatients with histologically proven NAFLD, who attended the outpatient clinic of the Gastroenterology Department, Gulhane School of Medicine, Ankara, Turkey
Key inclusion criteria (3 listed)
- Persistently (at least 6 months) elevated aminotransferases
- Ultrasonographic presence of bright liver without any other liver or biliary tract disease
- Liver histology compatible with a diagnosis of NASH or SS
Key exclusion criteria (6 listed)
- A history of alcohol consumption >40 g/wk, as assessed by a detailed interview extended to family members
- Morbid obesity [body mass index (BMI) ≥40 kg/m2], hypertension
- Positive blood markers of viral, autoimmune, or celiac disease
- Abnormal copper metabolism or thyroid function tests
- A diagnosis of T2DM and systemic arterial hypertension
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
For laboratory analyses, the collection of all blood samples from the study participants.
Time frame: Collection of blood samples in one year and analyses of data in 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2011.
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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.
halil genc, MD principal investigator
Gulhane Medical School
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 Non-alcoholic Fatty Liver Disease, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Nov 2011. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
For laboratory analyses, the collection of all blood samples from the study participants. (time frame: Collection of blood samples in one year and analyses of data in 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2011.