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

History of Changes

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:

MedlinePlus related topics: Diabetes

U.S. FDA Resources

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

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 May 21, 2013

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