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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01344694
Other study ID # 0020-11
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 27, 2011
Last updated May 13, 2011
Start date July 2011
Est. completion date March 2012

Study information

Verified date April 2011
Source Ziv Hospital
Contact Nimer Assy, MD
Phone 972-46828442
Email assy.n@ziv.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

Background: Visceral fat is increasingly associated with metabolic syndrome and with fatty liver, a condition carrying a high risk of cardiovascular disease. The independent role of epicardial fat deposition in cardiovascular risk remains unclear.


Description:

Background: Visceral fat is increasingly associated with metabolic syndrome and with fatty liver, a condition carrying a high risk of cardiovascular disease. The independent role of epicardial fat deposition in cardiovascular risk remains unclear. Aim: Evaluate the link between epicardial fat, visceral fat, liver fat accumulation and cardiovascular diseases and carotis atherosclerosis in patients with the major cardiovascular risk factors and with or without metabolic syndrome.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 110
Est. completion date March 2012
Est. primary completion date February 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria:

- Patients referred to cardiac CT will be the source of recruitment.

- patients with excess of visceral fat,

- 30 patients with liver fat accumulation

- 30 sex-age-matched individual (controls) will be enrolled. All patients will undergo a complete family history, personal clinical history, physical examination and blood sampling for biochemical analysis.

- Informed consent will be obtained from each individual.

Exclusion Criteria:

- subjects with severe morbid obesity (body mass index [BMI] > 40),

- recent history of acute illness,

- clinical history of ischemic heart disease and cerebrovascular disease,

- typical chest pain,

- previous coronary artery disease,

- conventional coronary angiography, percutaneous interventions, coronary by pass grafting, renal failure, cancer patients,

- subjects who take drugs that induces hepatic steatosis ( corticosteroids, estrogens, methotrexate, amiodarone and others)

Study Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
patient with liver fat
30 patient with liver fat
pts. with excess of visceral fat
pts. with excess of visceral fat
control
30 control subjects

Locations

Country Name City State
Israel Ziv MC Safed

Sponsors (1)

Lead Sponsor Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

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