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

NCT01472120 | Unknown

• 1 other identifier: NASH-macrophage
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

P and C

P: NAFLD patients C: Healthy controls

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gulhane School of Medicine: lead

Study Sites (1)

Gastroenterology Department, Gulhane School of Medicine

Ankara, 06018, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• halil genc, MD

  Gulhane Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gulhane School of Medicine

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: November 16, 2011
• Study Start: December 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: January 1, 2013
• Last Updated: November 16, 2011

Record last verified: 2011-08

Locations

TU (1)