Vascular Risk Progression in Normal and Diabetic Control Subjects.

NCT ID: NCT00579228

Last Updated: 2023-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-25

Study Completion Date

2018-03-29

Brief Summary

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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

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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.

Conditions

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Diabetes Inflammation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1 Cardiovascular disease (CVD) in Participants without diabetes

Progression of cardiovascular disease (CVD) in participants without diabetes

No interventions assigned to this group

2 Cardiovascular disease (CVD) in participants with type 2 Diabetes

Progression of cardiovascular disease (CVD) in participants with type 2 Diabetes with good control

No interventions assigned to this group

3 Cardiovascular disease (CVD) in participants with type 1 diabetes

Progression of cardiovascular disease (CVD) in participants with type 1 diabetes with good control

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Larsen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

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University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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0124-07-EP

Identifier Type: -

Identifier Source: org_study_id

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