Cardiovascular DiseasesWESCIDNCT00005539
Wisconsin Epidemiological Study of Cardiovascular Disease in Type 1 Diabetes
An observational study of Cardiovascular Diseases and Diabetes Mellitus, run by University of Wisconsin, Madison.
Trial summary
To investigate the prevalence and incidence rates of cardiovascular disease morbidity and mortality in people with Type 1 diabetes of long duration. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Diabetes Mellitus, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Feb 1999to Jan 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To investigate the prevalence and incidence rates of cardiovascular disease morbidity and mortality in people with Type 1 diabetes of long duration.
Read the 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 (i.e., A/V 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.
- Conditions
- Cardiovascular Diseases, Diabetes Mellitus, Heart Diseases, Diabetes Mellitus, Insulin-dependent
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Heart Diseases, Diabetes Mellitus, Type 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startFeb 1999
- Primary completionJan 2003
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Ronald Klein, MD, MPH, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005539
- Sponsor's protocol ID
- 1998-496
- Other IDs
- R01HL059259, 5079
- Acronym
- WESCID
- Status last verified
- Feb 2016
- First submitted
- 25 May 2000
- Last updated
- 8 Feb 2016
- Results posted
- No
Publications
Klein R, Klein BE, Moss SE, Cruickshanks KJ. Association of ocular disease and mortality in a diabetic population. Arch Ophthalmol. 1999 Nov;117(11):1487-95. doi: 10.1001/archopht.117.11.1487.
PubMed 10565517Valmadrid CT, Klein R, Moss SE, Klein BE, Cruickshanks KJ. Alcohol intake and the risk of coronary heart disease mortality in persons with older-onset diabetes mellitus. JAMA. 1999 Jul 21;282(3):239-46. doi: 10.1001/jama.282.3.239.
PubMed 10422992Wong TY, Cruickshank KJ, Klein R, Klein BE, Moss SE, Palta M, Riley WJ, Maclaren NK, Vadheim CM, Rotter JI. HLA-DR3 and DR4 and their relation to the incidence and progression of diabetic retinopathy. Ophthalmology. 2002 Feb;109(2):275-81. doi: 10.1016/s0161-6420(01)00925-3.
PubMed 11825808Wong TY, Klein R, Klein BE, Tielsch JM, Hubbard L, Nieto FJ. Retinal microvascular abnormalities and their relationship with hypertension, cardiovascular disease, and mortality. Surv Ophthalmol. 2001 Jul-Aug;46(1):59-80. doi: 10.1016/s0039-6257(01)00234-x.
PubMed 11525792Wong TY, Klein R. Retinal arteriolar emboli: epidemiology and risk of stroke. Curr Opin Ophthalmol. 2002 Jun;13(3):142-6. doi: 10.1097/00055735-200206000-00002.
PubMed 12011681Klein R. Prevention of visual loss from diabetic retinopathy. Surv Ophthalmol. 2002 Dec;47 Suppl 2:S246-52. doi: 10.1016/s0039-6257(02)00388-0.
PubMed 12507626Klein R, Klein BE, Moss SE, Wong TY, Hubbard L, Cruickshanks KJ, Palta M. The relation of retinal vessel caliber to the incidence and progression of diabetic retinopathy: XIX: the Wisconsin Epidemiologic Study of Diabetic Retinopathy. Arch Ophthalmol. 2004 Jan;122(1):76-83. doi: 10.1001/archopht.122.1.76.
PubMed 14718299Wang JJ, Mitchell P, Rochtchina E, Tan AG, Wong TY, Klein R. Retinal vessel wall signs and the 5 year incidence of age related maculopathy: the Blue Mountains Eye Study. Br J Ophthalmol. 2004 Jan;88(1):104-9. doi: 10.1136/bjo.88.1.104.
PubMed 14693785Wong TY, Shankar A, Klein R, Klein BE. Retinal vessel diameters and the incidence of gross proteinuria and renal insufficiency in people with type 1 diabetes. Diabetes. 2004 Jan;53(1):179-84. doi: 10.2337/diabetes.53.1.179.
PubMed 14693713Wang JJ, Mitchell P, Leung H, Rochtchina E, Wong TY, Klein R. Hypertensive retinal vessel wall signs in a general older population: the Blue Mountains Eye Study. Hypertension. 2003 Oct;42(4):534-41. doi: 10.1161/01.HYP.0000090122.38230.41. Epub 2003 Aug 25.
PubMed 12939235Leung H, Wang JJ, Rochtchina E, Tan AG, Wong TY, Hubbard LD, Klein R, Mitchell P. Computer-assisted retinal vessel measurement in an older population: correlation between right and left eyes. Clin Exp Ophthalmol. 2003 Aug;31(4):326-30. doi: 10.1046/j.1442-9071.2003.00661.x.
PubMed 12880458Tan AG, Wang JJ, Rochtchina E, Klein R, Wong TY, Hubbard LD, Mitchell P. Correlation between generalized and focal retinal arteriolar narrowing in an older population. Clin Exp Ophthalmol. 2003 Aug;31(4):322-5. doi: 10.1046/j.1442-9071.2003.00662.x.
PubMed 12880457Leung H, Wang JJ, Rochtchina E, Tan AG, Wong TY, Klein R, Hubbard LD, Mitchell P. Relationships between age, blood pressure, and retinal vessel diameters in an older population. Invest Ophthalmol Vis Sci. 2003 Jul;44(7):2900-4. doi: 10.1167/iovs.02-1114.
PubMed 12824229Klein R. Is intensive management of blood pressure to prevent visual loss in persons with type 2 diabetes indicated? Arch Ophthalmol. 2004 Nov;122(11):1707-9. doi: 10.1001/archopht.122.11.1707. No abstract available.
PubMed 15534135Klein BE, Klein R, Hall ER, Lee KE, Jensen K. The comparability of estimates of retroilluminated lens opacities as judged from film-based and digital imaging. Am J Ophthalmol. 2004 Oct;138(4):668-70. doi: 10.1016/j.ajo.2004.04.068.
PubMed 15488807
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wisconsin Epidemiological Study of Cardiovascular Disease in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00005539
- Acronym / sponsor ID
- WESCID / 1998-496
- Conditions
- Cardiovascular Diseases, Diabetes Mellitus, Heart Diseases, Diabetes Mellitus, Insulin-dependent
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 1999
- Primary completion
- Jan 2003 (actual)
- Study completion
- Jan 2003 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (i.e., A/V 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Background: PubMed 10565517Klein R, Klein BE, Moss SE, Cruickshanks KJ. Association of ocular disease and mortality in a diabetic population. Arch Ophthalmol. 1999 Nov;117(11):1487-95. doi: 10.1001/archopht.117.11.1487.
- Background: PubMed 10422992Valmadrid CT, Klein R, Moss SE, Klein BE, Cruickshanks KJ. Alcohol intake and the risk of coronary heart disease mortality in persons with older-onset diabetes mellitus. JAMA. 1999 Jul 21;282(3):239-46. doi: 10.1001/jama.282.3.239.
- Background: PubMed 11825808Wong TY, Cruickshank KJ, Klein R, Klein BE, Moss SE, Palta M, Riley WJ, Maclaren NK, Vadheim CM, Rotter JI. HLA-DR3 and DR4 and their relation to the incidence and progression of diabetic retinopathy. Ophthalmology. 2002 Feb;109(2):275-81. doi: 10.1016/s0161-6420(01)00925-3.
- Background: PubMed 11525792Wong TY, Klein R, Klein BE, Tielsch JM, Hubbard L, Nieto FJ. Retinal microvascular abnormalities and their relationship with hypertension, cardiovascular disease, and mortality. Surv Ophthalmol. 2001 Jul-Aug;46(1):59-80. doi: 10.1016/s0039-6257(01)00234-x.
- Background: PubMed 12011681Wong TY, Klein R. Retinal arteriolar emboli: epidemiology and risk of stroke. Curr Opin Ophthalmol. 2002 Jun;13(3):142-6. doi: 10.1097/00055735-200206000-00002.
- Background: PubMed 12507626Klein R. Prevention of visual loss from diabetic retinopathy. Surv Ophthalmol. 2002 Dec;47 Suppl 2:S246-52. doi: 10.1016/s0039-6257(02)00388-0.
- Background: PubMed 14718299Klein R, Klein BE, Moss SE, Wong TY, Hubbard L, Cruickshanks KJ, Palta M. The relation of retinal vessel caliber to the incidence and progression of diabetic retinopathy: XIX: the Wisconsin Epidemiologic Study of Diabetic Retinopathy. Arch Ophthalmol. 2004 Jan;122(1):76-83. doi: 10.1001/archopht.122.1.76.
- Background: PubMed 14693785Wang JJ, Mitchell P, Rochtchina E, Tan AG, Wong TY, Klein R. Retinal vessel wall signs and the 5 year incidence of age related maculopathy: the Blue Mountains Eye Study. Br J Ophthalmol. 2004 Jan;88(1):104-9. doi: 10.1136/bjo.88.1.104.
- Background: PubMed 14693713Wong TY, Shankar A, Klein R, Klein BE. Retinal vessel diameters and the incidence of gross proteinuria and renal insufficiency in people with type 1 diabetes. Diabetes. 2004 Jan;53(1):179-84. doi: 10.2337/diabetes.53.1.179.
- Background: PubMed 12939235Wang JJ, Mitchell P, Leung H, Rochtchina E, Wong TY, Klein R. Hypertensive retinal vessel wall signs in a general older population: the Blue Mountains Eye Study. Hypertension. 2003 Oct;42(4):534-41. doi: 10.1161/01.HYP.0000090122.38230.41. Epub 2003 Aug 25.
- Background: PubMed 12880458Leung H, Wang JJ, Rochtchina E, Tan AG, Wong TY, Hubbard LD, Klein R, Mitchell P. Computer-assisted retinal vessel measurement in an older population: correlation between right and left eyes. Clin Exp Ophthalmol. 2003 Aug;31(4):326-30. doi: 10.1046/j.1442-9071.2003.00661.x.
- Background: PubMed 12880457Tan AG, Wang JJ, Rochtchina E, Klein R, Wong TY, Hubbard LD, Mitchell P. Correlation between generalized and focal retinal arteriolar narrowing in an older population. Clin Exp Ophthalmol. 2003 Aug;31(4):322-5. doi: 10.1046/j.1442-9071.2003.00662.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Klein, MD, MPH principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Diabetes Mellitus, run by University of Wisconsin, Madison.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005539, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.