Vascular Risk Progression in Normal and Diabetic Control Subjects.

Diabetes Clinical Trial

Official title:

Vascular Risk Progression in Normal and Diabetes Control Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00579228
• Other study ID #: 0124-07-EP
• Status: Completed
• Start date: April 25, 2007
• Est. completion date: March 29, 2018

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 29, 2018
• Est. primary completion date: March 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Inflammation

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

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