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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Gulhane School of Medicine.
Recruitment status was  Not yet recruiting
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

August 11, 2011
November 15, 2011
December 2011
September 2012   (final data collection date for 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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01472120 on ClinicalTrials.gov Archive Site
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Adiponectin and Circulating Macrophage Phenotypes in Non-alcoholic Fatty Liver Disease (NAFLD)
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

A sample of male outpatients with histologically proven NAFLD, who attended the outpatient clinic of the Gastroenterology Department, Gulhane School of Medicine, Ankara, Turkey

Non-alcoholic Fatty Liver Disease
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P and C

P: NAFLD patients

C: Healthy controls

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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
160
January 2013
September 2012   (final data collection date for primary outcome measure)

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
Male
20 Years to 60 Years
Yes
Turkey
 
NCT01472120
NASH-macrophage
No
Halil Genc, Gulhane School of Medicine
Gulhane School of Medicine
Not Provided
Principal Investigator: halil genc, MD Gulhane Medical School
Gulhane School of Medicine
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP