Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005754
Status:
COMPLETED
Last Update Posted:
2015-06-10
First Post:
2000-05-25
Brief Title:
Coronary Artery Calcification in Type 1 Diabetes
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate the occurrence and associated risk factors for subclinical heart disease in persons with insulin-dependent diabetes mellitus IDDM
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 US IDDM affects at least 750000 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 spousepartner 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 spousespartners 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
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 US IDDM affects at least 750000 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 spousepartner 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 spousespartners 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL061753 | NIH | None | httpsreporternihgovquickSearchR01HL061753 |