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

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title:

The Relationship of Adiponectin With Circulating Macrophage Phenotypes in Non-alcoholic Fatty Liver Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01472120
• Other study ID #: NASH-macrophage
• Status: Not yet recruiting
• Phase: N/A
• First received: August 11, 2011
• Last updated: November 15, 2011
• Start date: December 2011
• Est. completion date: January 2013

Study information

• Verified date: August 2011
• Source: Gulhane School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: January 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Locations

Country	Name	City	State
Turkey	Gastroenterology Department, Gulhane School of Medicine	Ankara,

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane School of Medicine

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No