Cardiac CT's Role in Asymptomatic Patients With Diabetes and Metabolic Syndrome

NCT ID: NCT01564485

Last Updated: 2021-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 193 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2016-12-31

Brief Summary

This study looked at the role of cardiac CT in improving risk factor control in those with diabetes.

Detailed Description

This study examined whether doing a cardiac screening test, the cardiac CT, would result in patients paying more attention to controlling their risk factors.

Conditions

Diabetes; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Cardiac CT

Patients randomized to cardiac CT will obtain a non-invasive assessment of their coronary arteries.

Group Type: EXPERIMENTAL

Cardiac CT

Intervention Type: DIAGNOSTIC_TEST

A cardiac CT involves a non-invasive test of the coronary arteries.

Usual Care

Patients randomized to usual care will be assigned to continuing usual medical care with their primary care physician

Group Type: ACTIVE_COMPARATOR

Usual medical care

Intervention Type: BEHAVIORAL

Patients would be treated by their primary care physicians with usual medical care with drugs such as lipid lowering medication, blood pressure lowering medications, and blood glucose lowering medications. The study will not specify which drugs to use and will it up to the individual physician's discretion.

Interventions

Cardiac CT

A cardiac CT involves a non-invasive test of the coronary arteries.

Intervention Type: DIAGNOSTIC_TEST

Usual medical care

Patients would be treated by their primary care physicians with usual medical care with drugs such as lipid lowering medication, blood pressure lowering medications, and blood glucose lowering medications. The study will not specify which drugs to use and will it up to the individual physician's discretion.

Intervention Type: BEHAVIORAL

Other Intervention Names

Usual medical care would include control of blood pressure, blood glucose, and cholesterol by the primary care physician.

Eligibility Criteria

Inclusion Criteria

• Age > 18
• Diabetes
• Metabolic Syndrome

Exclusion Criteria

• Symptoms of heart disease
• Heart Disease
• Renal disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Shaista Malik

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaista Malik, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California, Irvine Medical Center

Orange, California, United States

Countries

United States

Other Identifiers

2008-6170

Identifier Type: -

Identifier Source: org_study_id