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Vascular Risk Progression in Normal and Diabetic Control Subjects.

University of Nebraska logo

University of Nebraska

Status

Completed

Conditions

Inflammation
Diabetes

Study type

Observational

Funder types

Other

Identifiers

NCT00579228
0124-07-EP

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

19 to 80 years old

Volunteers

Accepts Healthy Volunteers

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 > 130.
  • For Diabetes: BP> 135/85, A1C> 8%. LDL > 100.

Trial design

90 participants in 3 patient groups

1 Cardiovascular disease (CVD) in Participants without diabetes
Description:
Progression of cardiovascular disease (CVD) in participants without diabetes
2 Cardiovascular disease (CVD) in participants with type 2 Diabetes
Description:
Progression of cardiovascular disease (CVD) in participants with type 2 Diabetes with good control
3 Cardiovascular disease (CVD) in participants with type 1 diabetes
Description:
Progression of cardiovascular disease (CVD) in participants with type 1 diabetes with good control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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