Study to Evaluate Subclinical Atherosclerosis (an Early Sign of Heart Disease) in Healthy Adult Immigrant Asian Indians

Not Applicable

Withdrawn

• Conditions: Healthy

• Registration Number: NCT01104597
• Lead Sponsor: Northwell Health

Brief Summary

Previous research has shown that Asian Indians are at relatively high risk for developing diabetes, heart problems and high blood pressure.

The purpose of this study is to evaluate subclinical atherosclerosis (an early sign of heart disease) which may be associated with abnormalities like diabetes mellitus, hypertension (high blood pressure), high cholesterol and heart problems.

Endothelium is the inner lining of your blood vessels. Endothelial dysfunction is found more in people with diabetes. In addition, high body mass index (BMI) is a strong risk factor for developing metabolic abnormalities like diabetes mellitus. This research study may provide information as to how useful endothelial dysfunction will be to detect people at risk of metabolic abnormalities and heart disease at an early stage.

Two groups of subjects will be enrolled. Caucasians and Asian Indians There will be a total of 100 subjects participating in this study. Approximately 50 Caucasians and 50 Asian Indians will be enrolled. Caucasians will serve as the control group for this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-09
• Study First Submitted QC: 2010-04-14
• Study First Posted: 2010-04-15
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-10
• Last Update Posted: 2013-06-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Asian Indians and Caucasians between the ages of 20 and 65 living in the boroughs of New York City and the Long Island area.

Subjects must provide a record of blood results completed within the past year to determine eligibility (hematology and chemistry results).

Exclusion Criteria

• Subjects with major underlying medical problems, including diabetes, hypertension, coronary artery disease (CAD), hyperlipidemia, systolic blood pressure below 90 mm Hg and liver or kidney disease will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Assessment of subclinical atherosclerosis in healthy adult immigrant Asian Indians using flow mediated endothelial dysfunction method	April 2010 to April 2012	To evaluate subclinical atherosclerosis (an early sign of heart disease) which may be associated with abnormalities like diabetes mellitus, hypertension (high blood pressure), high cholesterol and heart problems.