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

NCT01564485 | Completed Results DMC FDA Device

• 1 other identifier: 2008-6170
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Systolic BP Pressure

  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.

  Five year follow up

Other Outcomes (1)

• Change in Treatment by PCP

  2 years

Study Arms (2)

Cardiac CT

EXPERIMENTAL

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

Diagnostic Test: Cardiac CT

Usual Care

ACTIVE COMPARATOR

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

Behavioral: Usual medical care

Interventions

Cardiac CT DIAGNOSTIC_TEST

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

Cardiac CT

Usual medical care 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.

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

Usual Care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18
• Diabetes
• Metabolic Syndrome

You may not qualify if:

• Symptoms of heart disease
• Heart Disease
• Renal disease

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Metabolic Syndrome

Interventions

Blood Glucose

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Glucose; Hexoses; Monosaccharides; Sugars; Carbohydrates

Results Point of Contact

• Title: Ashwini Erande, Clinical Coordinator
• Organization: University of California, Irvine

aerande@uci.edu

714 456 7025

Study Officials

• Shaista Malik, MD, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: March 27, 2012
• Study Start: July 1, 2008
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 8, 2021
• Results First Posted: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data is now available
• Access Criteria: We will need written request to share data

Locations

US (1)