Vascular Risk Progression in Normal and Diabetic Control Subjects.

Vascular Risk Progression in Normal and Diabetes Control Subjects

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00579228

Enrollment

Registered

2007-12-24

Start date

2007-04-25

Completion date

2018-03-29

Last updated

2023-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Inflammation

Keywords

Diabetes, Vascular risk, Inflammation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Carotid intima media measurement change	2 years	To describe carotid intima media measurement change over 2 year period in normal individuals compared to individuals with well controlled diabetes

Countries

United States

Outcome results