NCT01344694

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

May 16, 2011

Status Verified

April 1, 2011

Enrollment Period

7 months

First QC Date

April 27, 2011

Last Update Submit

May 13, 2011

Conditions

Epicardial FatVisceral FatAtherosclerosis

Keywords

Epicardial fatVisceral fatatherosclerosiscoronary computed tomography angiographyCarotid Doppler ultrasound

Study Arms (3)

patient with liver fat

30 patients with liver fat

Other: patient with liver fat

excess of visceral fat

50 pts. with excess of visceral fat

Other: pts. with excess of visceral fat

control

30 control subjects

Other: control

Interventions

patient with liver fatOTHER

30 patient with liver fat

patient with liver fat
pts. with excess of visceral fatOTHER

pts. with excess of visceral fat

excess of visceral fat
controlOTHER

30 control subjects

control

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

50 patients (age 40-70) with excess of visceral fat (obese), 30 patient with liver fat and 30 sexes, age matched individuals will be recruited.

You may qualify if:

  • Patients referred to cardiac CT will be the source of recruitment.
  • patients with excess of visceral fat,
  • patients with liver fat accumulation
  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziv MC

Safed, 13100, Israel

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

6-pyruvoyltetrahydropterin synthase

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Nimer Assy, md

    Ziv MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nimer Assy, MD

CONTACT

972-46828442assy.n@ziv.health.gov.il

Nimer Assy

CONTACT

972-46828442assy.n@ziv.health.gov.il

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 27, 2011

First Posted

April 29, 2011

Study Start

July 1, 2011

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

May 16, 2011

Record last verified: 2011-04

Locations

IL(1)