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.

Study Overview

• Status: Unknown
• Conditions: Non-alcoholic Fatty Liver Disease

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 Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

Study Locations

• Turkey
  • Ankara,, Turkey, 06018
    • Gastroenterology Department, Gulhane School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
P and C; P: NAFLD patients C: Healthy controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
For laboratory analyses, the collection of all blood samples from the study participants.	Collection of blood samples in one year and analyses of data in 3 months.

Collaborators and Investigators

• Sponsor: Gulhane School of Medicine
• Investigators: Principal Investigator: halil genc, MD, Gulhane Medical School

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): September 1, 2012
• Study Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: August 11, 2011
• First Submitted That Met QC Criteria: November 15, 2011
• First Posted (Estimate): November 16, 2011

Study Record Updates

• Last Update Posted (Estimate): November 16, 2011
• Last Update Submitted That Met QC Criteria: November 15, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: NASH-macrophage