Adiponectin and Circulating Macrophage Phenotypes in Non-alcoholic Fatty Liver Disease (NAFLD)

NCT ID: NCT01472120

Last Updated: 2011-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-01-31

Brief Summary

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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

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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

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Non-alcoholic Fatty Liver Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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P and C

P: NAFLD patients

C: Healthy controls

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gulhane School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Halil Genc

Gulhane School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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halil genc, MD

Role: PRINCIPAL_INVESTIGATOR

Gulhane Medical School

Locations

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Gastroenterology Department, Gulhane School of Medicine

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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NASH-macrophage

Identifier Type: -

Identifier Source: org_study_id