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Clinical Trials/NCT00579228
NCT00579228
Completed
Not Applicable

Vascular Risk Progression in Normal and Diabetes Control Subjects

University of Nebraska1 site in 1 country90 target enrollmentApril 25, 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes
Sponsor
University of Nebraska
Enrollment
90
Locations
1
Primary Endpoint
Carotid intima media measurement change
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this study is to look at the progression of cardiovascular disease (CVD) in normal control individuals and in patients with controlled diabetes.

Detailed Description

Cardiovascular disease remains the greatest cause of mortality in people with diabetes mellitus. This observation study will evaluate non-traditional risk factors for their contributions to vascular disease progression as determined by carotid intima media thickness and history of vascular disease events over 1 year. This study requires annual checks of blood, urine, history, and carotid ultrasound for carotid intimal medical thickness.

Registry
clinicaltrials.gov
Start Date
April 25, 2007
End Date
March 29, 2018
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 19 years old or more and willing to return for annual testing for 2 years.
  • Those with Diabetes need to have the condition for at least 5 years.
  • Normal controls need to have no diabetes, kidney disease, or chronic disease.

Exclusion Criteria

  • Estimated GFR \<60 (mL/min/1.73m2)
  • Any condition that would change weight dramatically in the near future such as malabsorption, pregnancy, malignancy
  • For Normal: BMI\>30, BP \> 140/90 , LDL \>
  • For Diabetes: BP\> 135/85, A1C\> 8%. LDL \> 100.

Outcomes

Primary Outcomes

Carotid intima media measurement change

Time Frame: 2 years

To describe carotid intima media measurement change over 2 year period in normal individuals compared to individuals with well controlled diabetes

Study Sites (1)

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