Coronary Artery Calcification in Type 1 Diabetes

June 8, 2015 updated by: University of Colorado, Denver
To investigate the occurrence and associated risk factors for subclinical heart disease in persons with insulin-dependent diabetes mellitus (IDDM).

Study Overview

Status

Completed

Conditions

Detailed Description

BACKGROUND:

Approximately 10 percent of premature coronary artery disease (CAD) morbidity and mortality in the general population is due to insulin dependent diabetes mellitus (IDDM). By age 55, 35 percent of IDDM patents die of CAD, in contrast to only 8 percent of nondiabetic men and 4 percent of women. In the U.S., IDDM affects at least 750,000 persons and this number is growing rapidly as the effect of increasing incidence and improved survival. Tight blood glucose control can slow the development of microvascular complications but a protective effect on heart disease has not been convincingly demonstrated.

DESIGN NARRATIVE:

This observational population-based study evaluated cross- sectionally a population-based group of 656 IDDM patients aged 20-55 years and 764 of their non-diabetic spouse/partner controls using the electron-beam computed tomography (EBCT). Patients and controls were compared in terms of the amount and anatomical distribution of coronary artery calcium (CAC), a marker of atherosclerosis, and the left ventricular (LV) area, a marker of LV hypertrophy and diabetic cardiomyopathy. The demographic, metabolic, and behavioral factors associated with increased CACand LV area were defined. Standard epidemiological methods were used to determine the prevalence of clinical CAD, defined by previous MI, revascularization, or angina in the study population. In 100 asymptomatic high-risk IDDM patients (CAC greater than or equal to 20 or LV area greater than 60 cm2), in 50 low-risk patients (CAC and LV area below these cut-offs), and in 20 nondiabetic controls age-sex matched to the high-risk patients, ECG-gated rest-stress technetium-99m sestamibi single-photon emission computed tomographic imaging (MIBI SPECT) was performed. This helped to determine the presence of myocardial perfusion defects and to quantify myocardial perfusion reserve as well as to relate these findings anatomically to the distribution of CAC by EBCT. In addition, LV volumes, ejection fraction, wall motion and thickening were determined, and related to LV area by EBCT. Finally, the study cohort of 656 IDDM patients and 764 non diabetic spouses/partners were followed up for a period of 3 years to measure the change in CAC and LV area using a repeat EBCT and to identify the metabolic and behavioral risk factors for progression in these indices. Cause-specific mortality was monitored and all fatal and non-fatal cardiac events were ascertained. In the subgroup of 100 high-risk IDDM patients studied with the MIBI SPECT at the baseline and in all low-risk patients whose CAC increased by more than 50 during the follow-up, MIBI SPECT was used to evaluate the change in myocardial perfusion, LV volumes, ejection fraction, wall motion and thickening, as well as to relate these findings to the change in CAC and LV area by EBCT.

The study was extended to follow the cohort for an additional three years to achieve the following specific aims: 1. To determine, among type 1 diabetic (T1D) patients and comparable controls, the risk factors for: a. 6-year progression of electron-beam tomography (EBT) defined coronary calcification - marker of coronary atherosclerosis b. 6-year development of myocardial perfusion defects and changes in relative myocardial perfusion reserve defined using ECG-gated rest-stress technetium-99m MIBI SPECT imaging c. 6-year incidence of clinical CAD, defined by fatal and non-fatal MI, revascularization or angina, as well as stroke, peripheral artery disease and cause-specific mortality. 2. To develop a clinically useful measure of insulin sensitivity that is directly comparable between T1D patients and non-diabetic persons to more precisely determine the role of insulin resistance in development of premature CAC in type I diabetes.

Study Type

Observational

Enrollment (Actual)

1420

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

656 IDDM patients aged 20-55 years and 764 of their non-diabetic spouse/partner controls

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression of coronary artery calcification
Time Frame: 12 years
12 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Marian Rewers, MD, PhD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1999

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (Estimate)

May 26, 2000

Study Record Updates

Last Update Posted (Estimate)

June 10, 2015

Last Update Submitted That Met QC Criteria

June 8, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 97-661
  • R01HL061753 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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