Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005539
Status:
COMPLETED
Last Update Posted:
2016-02-08
First Post:
2000-05-25
Brief Title:
Wisconsin Epidemiological Study of Cardiovascular Disease in Type 1 Diabetes
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Wisconsin Epidemiological Study of Cardiovascular Disease in Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2016-02
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:
WESCID
Brief Summary:
To investigate the prevalence and incidence rates of cardiovascular disease morbidity and mortality in people with Type 1 diabetes of long duration
Detailed Description:
BACKGROUND
With recent advances in diabetes treatment especially the evidence that tight control of glycemia diminishes glycemia related complications it is becoming apparent that the main barriers to further increases in the longevity of patients with insulin-dependent type 1 diabetes mellitus are the long-term cardiovascular complications of this condition However development of effective strategies to prevent cardiovascular complications of diabetes have been impeded by uncertainty as to the relative importance in their pathogenesis of hyperglycemia early renal dysfunction or excess levels of conventional risk factors In this context research to elucidate the predictors of cardiovascular complications of diabetes in well-characterized populations followed long term has the potential to be of considerable clinical and public health importance
DESIGN NARRATIVE
The study was a population-based longitudinal cohort study to determine the prevalence and incidence rates of cardiovascular disease morbidity and mortality in people with Type 1 diabetes of long duration The mean age of the cohort and the long duration of diabetes provided an opportunity to document the prevalence and incidence of coronary heart disease myocardial infarction angina congestive heart failure stroke transient ischemic attacks peripheral vascular disease and cardiovascular disease mortality in a large population-base group of persons with Type 1 diabetes Standardized protocols for exams and interviews were used during the baseline 4- 10- and 14-year follow-up exams Retinal photographs of each study participant were taken at the baseline examination This permitted the investigators to test the predictive ability of focal and generalized retinal arteriolar narrowing and arteriovenous crossing changes ie AV nicking for subsequent macrovascular events controlling for other risk factors These factors included blood pressure cigarette smoking serum lipids body mass index duration of diabetes and glycemia
The cohort was re-examined to obtain ECGs blood lipid fractions not previously measured and fibrinogen as well as upper and lower extremity blood pressures urine specimens and medical records This provided information about silent infarctions and other cardiographic abnormalities as well as previously doctor-diagnosed macrovascular events in long-term survivors of Type 1 diabetes Study examinations were performed in a mobile van Participants provided two urine specimens for determination of urinary albumin excretion Fasting blood was obtained for determination of glycosylated hemoglobin A1c blood sugar serum cholesterol triglycerides HDL-cholesterol LDL-cholesterol VLDL-cholesterol LDL particle size serum creatinine and fibrinogen Additional study procedures included measurements of weight and height waist and hip girth and brachial and ankle blood pressures Electrocardiography was also performed A questionnaire was administered Participants were subsequently interviewed yearly and clinical and hospital records and death certificates were collected to document new cardiovascular disease events
With recent advances in diabetes treatment especially the evidence that tight control of glycemia diminishes glycemia related complications it is becoming apparent that the main barriers to further increases in the longevity of patients with insulin-dependent type 1 diabetes mellitus are the long-term cardiovascular complications of this condition However development of effective strategies to prevent cardiovascular complications of diabetes have been impeded by uncertainty as to the relative importance in their pathogenesis of hyperglycemia early renal dysfunction or excess levels of conventional risk factors In this context research to elucidate the predictors of cardiovascular complications of diabetes in well-characterized populations followed long term has the potential to be of considerable clinical and public health importance
DESIGN NARRATIVE
The study was a population-based longitudinal cohort study to determine the prevalence and incidence rates of cardiovascular disease morbidity and mortality in people with Type 1 diabetes of long duration The mean age of the cohort and the long duration of diabetes provided an opportunity to document the prevalence and incidence of coronary heart disease myocardial infarction angina congestive heart failure stroke transient ischemic attacks peripheral vascular disease and cardiovascular disease mortality in a large population-base group of persons with Type 1 diabetes Standardized protocols for exams and interviews were used during the baseline 4- 10- and 14-year follow-up exams Retinal photographs of each study participant were taken at the baseline examination This permitted the investigators to test the predictive ability of focal and generalized retinal arteriolar narrowing and arteriovenous crossing changes ie AV nicking for subsequent macrovascular events controlling for other risk factors These factors included blood pressure cigarette smoking serum lipids body mass index duration of diabetes and glycemia
The cohort was re-examined to obtain ECGs blood lipid fractions not previously measured and fibrinogen as well as upper and lower extremity blood pressures urine specimens and medical records This provided information about silent infarctions and other cardiographic abnormalities as well as previously doctor-diagnosed macrovascular events in long-term survivors of Type 1 diabetes Study examinations were performed in a mobile van Participants provided two urine specimens for determination of urinary albumin excretion Fasting blood was obtained for determination of glycosylated hemoglobin A1c blood sugar serum cholesterol triglycerides HDL-cholesterol LDL-cholesterol VLDL-cholesterol LDL particle size serum creatinine and fibrinogen Additional study procedures included measurements of weight and height waist and hip girth and brachial and ankle blood pressures Electrocardiography was also performed A questionnaire was administered Participants were subsequently interviewed yearly and clinical and hospital records and death certificates were collected to document new cardiovascular disease events
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 |
|---|---|---|---|
| 5079 | OTHER | Study Team | httpsreporternihgovquickSearchR01HL059259 |
| R01HL059259 | NIH | None | None |