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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shaista Malik, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01564485
First received: February 24, 2012
Last updated: March 27, 2012
Last verified: March 2012
History of Changes
  Purpose

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


Condition Intervention
Diabetes
Metabolic Syndrome
 Procedure: Cardiac CT
Drug: Usual medical care

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Role of Cardiac CT in Risk Factor Control in Asymptomatic Patients With Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Systolic BP pressure [ Time Frame: Five year follow up ] [ Designated as safety issue: No ]
    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 both a continuous measure, as well as a categorical variable (<135 mm Hg, and >=135 mmHg)

  • Control of LDL cholesterol [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    We will assess the control of LDL cholesterol at 6 month intervals for a total of 5 years. We will assess this measure as a continuous variable and as a a dichotomous outcome (LDL < or = 100 or LDL >100)

  • Hemoglobin A1c [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    After the cardiac CT, we will assess if patients have better control of their hemoglobin A1c (we will assess every 6 months for a total of 5 years). This will be a continuous measure.


Estimated Enrollment: 250
Study Start Date: July 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cardiac CT
Patients randomized to cardiac CT will obtain a non-invasive assessment of their coronary arteries.
 Procedure: Cardiac CT
A cardiac CT involves a non-invasive test of the coronary arteries.
Placebo Comparator: Usual Care
Patients randomized to usual care will be assigned to continuing usual medical care with their primary care physician
 Drug: 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.
Other Name: Usual medical care would include control of blood pressure, blood glucose, and cholesterol by the primary care physician.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age > 18
  • Diabetes
  • Metabolic Sydrome

Exclusion Criteria:

  • Symptoms of heart disease
  • Heart Disease
  • Renal disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01564485

Locations
United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Shaista Malik, MD, PhD University of California, Irvine
  More Information

No publications provided

Responsible Party: Shaista Malik, Assistant Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01564485     History of Changes
Other Study ID Numbers: 20086170
Study First Received: February 24, 2012
Last Updated: March 27, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on June 13, 2013