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Vascular Risk Progression in Normal and Diabetic Control Subjects.

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Jennifer Larsen, MD, University of Nebraska Identifier:
First received: December 19, 2007
Last updated: May 11, 2017
Last verified: May 2017
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.

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)
Normal controls both men and women
Individuals with type 2 Diabetes with good control
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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00579228

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

Responsible Party: Jennifer Larsen, MD, Vice Chancelor of Research, University of Nebraska Identifier: NCT00579228     History of Changes
Other Study ID Numbers: 124-07
Study First Received: December 19, 2007
Last Updated: May 11, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Pathologic Processes processed this record on August 22, 2017