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Risk Factors for Atherogenesis in Type 1 Diabetes

This study has been completed.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00035750
  Purpose

To determine risk factors for atherogenesis in Type 1 diabetes.


Condition
Atherosclerosis
Cardiovascular Diseases
Diabetes Mellitus, Insulin-Dependent
Heart Diseases
Diabetes Mellitus

MedlinePlus related topics:   Diabetes    Diabetes Type 1    Heart Diseases   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Natural History, Defined Population

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:   September 2001
Estimated Study Completion Date:   August 2005

Detailed Description:

BACKGROUND:

Individuals with Type 1 diabetes have substantially higher risk for premature atherosclerotic vascular disease (ASVD) than the general population. Risk factors for the development of ASVD have been identified, but linking them to initiation of atherosclerosis was not feasible until recently. Advances in non-invasive imaging now permit early detection of changes in blood vessel function and structure. This imaging provides an opportunity to evaluate risk factors for ASVD and vascular status in a cohort at a critical time for development and early progression of ASVD.

DESIGN NARRATIVE:

Subjects were enrolled from 1987-1992 and were followed from diabetes diagnosis. Standardized protocols for examinations and interviews were implemented and the data base included a valuable longitudinal plasma bank. Because incident cases were enrolled, information was collected from diagnosis on children, adolescents and young adults currently without symptoms of atherosclerosis. The existing database was expanded, the existing resources were used including the plasma bank, and promising new and well established clinical research techniques were incorporated by: (i) measuring plasma lipid levels on stored plasma and on newly collected blood samples, (ii) measuring triglyceride levels on newly collected blood samples, (iii) measuring urinary albumin excretion rates on newly collected specimens (already measured from diagnosis to date), and (iv) assessing endothelial function by brachial artery ultrasound, (v) measuring the intima medial thickness (IMT) of the carotid artery by ultrasound, and (vi) measuring coronary calcium by computed tomography scanning. These activities allowed pursuit of the following specific aims: 1) to determine the relationship between established risk factors for atherosclerosis and the development of pre-clinical atherosclerosis, 2) to determine the relationship between endothelial dysfunction and carotid IMT, and 3) to determine the relationship between coronary artery calcification and carotid IMT. Such information was critical in directing further efforts toward primary prevention of atherosclerosis in individuals with Type 1 diabetes mellitus.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

No eligibility criteria

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035750

Sponsors and Collaborators

Investigators
Investigator:     Mari Palta     University of Wisconsin, Madison    
  More Information


Publications:

Study ID Numbers:   1054
First Received:   May 4, 2002
Last Updated:   November 10, 2005
ClinicalTrials.gov Identifier:   NCT00035750
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Atherosclerosis
Arterial Occlusive Diseases
Heart Diseases
Metabolic Diseases
Autoimmune Diseases
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Arteriosclerosis
Diabetes Mellitus, Type 1
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder

Additional relevant MeSH terms:
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 24, 2008




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