Trial record 18 of 93 for:    "ACDC"

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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Liver Diseases
Fatty Liver
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014