We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Coronary Artery Calcification in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00005754
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : June 10, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
To investigate the occurrence and associated risk factors for subclinical heart disease in persons with insulin-dependent diabetes mellitus (IDDM).

Condition or disease
Cardiovascular Diseases Heart Diseases Coronary Disease Diabetes Mellitus Diabetes Mellitus, Insulin-dependent

Detailed Description:


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.


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 Design

Study Type : Observational
Actual Enrollment : 1420 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : September 1999
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Progression of coronary artery calcification [ Time Frame: 12 years ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
656 IDDM patients aged 20-55 years and 764 of their non-diabetic spouse/partner controls
No eligibility criteria
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005754

Sponsors and Collaborators
University of Colorado, Denver
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Marian Rewers, MD, PhD University of Colorado, Denver
More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00005754     History of Changes
Other Study ID Numbers: 97-661
R01HL061753 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Myocardial Ischemia
Vascular Diseases
Arterial Occlusive Diseases
Autoimmune Diseases
Immune System Diseases