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

This study is not yet open for participant recruitment.
Verified August 2011 by Gulhane School of Medicine
Sponsor:
Information provided by (Responsible Party):
Halil Genc, Gulhane School of Medicine
ClinicalTrials.gov Identifier:
NCT01472120
First received: August 11, 2011
Last updated: November 15, 2011
Last verified: August 2011
  Purpose

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.


Condition
Non-alcoholic Fatty Liver Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Relationship of Adiponectin With Circulating Macrophage Phenotypes in Non-alcoholic Fatty Liver Disease

Resource links provided by NLM:


Further study details as provided by Gulhane School of Medicine:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: December 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
P and C

P: NAFLD patients

C: Healthy controls


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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472120

Locations
Turkey
Gastroenterology Department, Gulhane School of Medicine
Ankara,, Turkey, 06018
Sponsors and Collaborators
Gulhane School of Medicine
Investigators
Principal Investigator: halil genc, MD Gulhane Medical School
  More Information

No publications provided

Responsible Party: Halil Genc, Gulhane School of Medicine
ClinicalTrials.gov Identifier: NCT01472120     History of Changes
Other Study ID Numbers: NASH-macrophage
Study First Received: August 11, 2011
Last Updated: November 15, 2011
Health Authority: Turkey: Ethics Committee

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 21, 2013