Vascular Risk Progression in Normal and Diabetic Control Subjects.

This study is currently recruiting participants.

Verified by University of Nebraska, June 2008

First Received: December 19, 2007 Last Updated: June 2, 2008 History of Changes

Sponsored by:	University of Nebraska
Information provided by:	University of Nebraska
ClinicalTrials.gov Identifier:	NCT00579228

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:	Cohort, 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

Keywords provided by University of Nebraska:

Diabetes
Vascular risk
Inflammation

Study placed in the following topic categories:

Metabolic Diseases
Disease Progression
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Metabolic Diseases
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Inflammation

ClinicalTrials.gov processed this record on September 10, 2009