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

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Diabetes
• Interventions: Behavioral: Usual medical care; Diagnostic Test: Cardiac CT

• Registration Number: NCT01564485
• Lead Sponsor: University of California, Irvine

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2012-02-24
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-27
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2018-01-11
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-07
• Last Update Submitted: 2021-06-07
• Results First Posted: 2021-06-08
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

Inclusion Criteria

• Age > 18
• Diabetes
• Metabolic Syndrome

Exclusion Criteria

• Symptoms of heart disease
• Heart Disease
• Renal disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual medical care	Patients randomized to usual care will be assigned to continuing usual medical care with their primary care physician
Cardiac CT	Cardiac CT	Patients randomized to cardiac CT will obtain a non-invasive assessment of their coronary arteries.

Primary Outcome Measures

Name	Time	Method
Systolic BP Pressure	Five year follow up	After randomization to either obtain cardiac CT or usual care, patients will be followed for 5 years (with assessment of outcomes at every 6 months) to see any difference in control of systolic blood pressure. The outcome with be assessed as a continuous measure.

Trial Locations

Locations (1)

University of California, Irvine Medical Center; 🇺🇸 Orange, California, United States