Risk Factors for Atherogenesis in Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00035750
First received: May 4, 2002
Last updated: November 10, 2005
Last verified: October 2005
  Purpose

To determine risk factors for atherogenesis in Type 1 diabetes.


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

Study Type: Observational
Study Design: Observational Model: Defined Population

Resource links provided by NLM:


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

Additional relevant MeSH terms:
Atherosclerosis
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 1
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014