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OpenTrials
Completed

NCT Number: NCT00579228

Vascular Risk Progression in Normal and Diabetic Control Subjects.

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Inflammation Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Carotid intima media measurement change

    Time frame: 2 years

    To describe carotid intima media measurement change over 2 year period in normal individuals compared to individuals with well controlled diabetes

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

Vascular Risk Progression in Normal and Diabetes Control Subjects

Important dates

Study start
2007
Primary completion
2018
Study completion
2018
First posted
Dec 24, 2007
Registry last updated
Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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