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CompletedNCT00579228Updated Sep 14, 2023

Vascular Risk Progression in Normal and Diabetic Control Subjects.

An observational study in Diabetes and Inflammation, sponsored by University of Nebraska. Completed at 1 site in United States. Open to participants aged 19 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-14.

Sponsored by University of Nebraska · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
19 Years to 80 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Diabetes
  • Inflammation

Keywords

  • Diabetes
  • Vascular risk
  • Inflammation
03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 90 is below the median of 234 across 2,254 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University of Nebraska is the lead sponsor of 495 studies on the registry; 68 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 52 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Any patient with diabetes or healthy individuals

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (actual)

Groups and cohorts

  • 1 Cardiovascular disease (CVD) in Participants without diabetes

    Progression of cardiovascular disease (CVD) in participants without diabetes

  • 2 Cardiovascular disease (CVD) in participants with type 2 Diabetes

    Progression of cardiovascular disease (CVD) in participants with type 2 Diabetes with good control

  • 3 Cardiovascular disease (CVD) in participants with type 1 diabetes

    Progression of cardiovascular disease (CVD) in participants with type 1 diabetes with good control

06

What researchers measure

Primary outcomes

  1. Carotid intima media measurement change

    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

07

Study locations

1 site
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00579228
Responsible party
Sponsor
First posted
Dec 24, 2007
Start date
Apr 25, 2007
Primary completion
Mar 29, 2018
Completion
Mar 29, 2018
Last update
Sep 14, 2023

Study contacts

Jennifer Larsen, MD
principal investigator · University of Nebraska

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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