Vascular Risk Progression in Normal and Diabetic Control Subjects.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00579228
First received: December 19, 2007
Last updated: June 2, 2008
Last verified: June 2008
  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

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2007
Estimated Study Completion Date: December 2010
Estimated 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

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00579228

Contacts
Contact: Jillian M. Witte, RN,BSN 402-559-8553 jmwitte@unmc.edu
Contact: Olga Ostmann, MD 402-559-2274 oostmann@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-3020
Contact: Olga Ostmann, MD    402-559-2274    oostmann@unmc.edu   
Contact: Jillian Witte, RN,BSN    402-559-8553    jmwitte@unmc.edu   
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Jennifer Larsen, MD UNMC
  More Information

No publications provided

Responsible Party: Dr. Jennifer Larsen, UNMC
ClinicalTrials.gov Identifier: NCT00579228     History of Changes
Other Study ID Numbers: UNMC-IRB-124-07
Study First Received: December 19, 2007
Last Updated: June 2, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Diabetes
Vascular risk
Inflammation

Additional relevant MeSH terms:
Diabetes Mellitus
Inflammation
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014