Adiponectin and Circulating Macrophage Phenotypes in Non-alcoholic Fatty Liver Disease (NAFLD)
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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 |
- 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 |
A sample of male outpatients with histologically proven NAFLD, who attended the outpatient clinic of the Gastroenterology Department, Gulhane School of Medicine, Ankara, Turkey
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| Turkey | |
| Gastroenterology Department, Gulhane School of Medicine | |
| Ankara,, Turkey, 06018 | |
| 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:
|
Fatty Liver Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013