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

• Conditions: Non-alcoholic Fatty Liver Disease

• Registration Number: NCT01472120
• Lead Sponsor: Gulhane School of Medicine

Brief Summary

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

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 Timeline

• Status Verified: 2011-08
• Study First Submitted: 2011-08-11
• Study First Submitted QC: 2011-11-15
• Last Update Submitted: 2011-11-15
• Study First Posted: 2011-11-16
• Last Update Posted: 2011-11-16
• Study Start: 2011-12
• Primary Completion: 2012-09
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Gastroenterology Department, Gulhane School of Medicine; 🇹🇷 Ankara,, Turkey