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Vascular Risk Progression in Normal and Diabetic Control Subjects.

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ClinicalTrials.gov Identifier: NCT00579228
Recruitment Status : Completed
First Posted : December 24, 2007
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Jennifer Larsen, MD, University of Nebraska

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.

Condition or disease
Diabetes Inflammation

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.

Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vascular Risk Progression in Normal and Diabetes Control Subjects
Study Start Date : March 2007
Actual Primary Completion Date : March 29, 2018
Actual Study Completion Date : March 29, 2018

Group/Cohort
1
Normal controls both men and women
2
Individuals with type 2 Diabetes with good control
3
Individuals with type 1 diabetes with good control



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Any patient with diabetes or healthy individuals
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00579228


Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3020
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Jennifer Larsen, MD UNMC

Responsible Party: Jennifer Larsen, MD, Vice Chancelor of Research, University of Nebraska
ClinicalTrials.gov Identifier: NCT00579228     History of Changes
Other Study ID Numbers: 124-07
First Posted: December 24, 2007    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jennifer Larsen, MD, University of Nebraska:
Diabetes
Vascular risk
Inflammation

Additional relevant MeSH terms:
Inflammation
Pathologic Processes