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Vascular Risk Progression in Normal and Diabetic Control Subjects.

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00579228
First Posted: December 24, 2007
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jennifer Larsen, MD, University of Nebraska
  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.

Condition
Diabetes Inflammation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vascular Risk Progression in Normal and Diabetes Control Subjects

Further study details as provided by Jennifer Larsen, MD, University of Nebraska:

Primary Outcome Measures:
  • 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 ]

Enrollment: 90
Study Start Date: March 2007
Estimated Study Completion Date: December 2017
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
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.
  Contacts and Locations
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
  More Information

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 Submitted: December 19, 2007
First Posted: December 24, 2007
Last Update Posted: May 15, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Inflammation
Pathologic Processes