Expired Study
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Omaha, Nebraska 68198


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

124-07


NCT ID:

NCT00579228


Secondary ID:


Study Acronym:


Brief Title:

Vascular Risk Progression in Normal and Diabetic Control Subjects.


Official Title:

Vascular Risk Progression in Normal and Diabetes Control Subjects


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

19 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Nebraska


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

3


Total Enrollment:

90


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jennifer Larsen, MD
Principal Investigator
UNMC

Study Dates

Start Date:March 2007
Completion Date:March 29, 2018
Completion Type:Actual
Primary Completion Date:March 29, 2018
Primary Completion Type:Actual
Verification Date:March 2018
Last Changed Date:March 29, 2018
First Received Date:December 19, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:To describe carotid intima media measurement change over 2 year period in normal individuals compared to individuals with well controlled diabetes
Time Frame:2 years
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:1
Description:Normal controls both men and women
Study Arm Type:Other
Arm Name:2
Description:Individuals with type 2 Diabetes with good control
Study Arm Type:Other
Arm Name:3
Description:Individuals with type 1 diabetes with good control

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Nebraska

Samples and Retentions

Study Population: Any patient with diabetes or healthy individuals
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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