NCT00579228

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2007

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2018

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

10.9 years

First QC Date

December 19, 2007

Last Update Submit

September 12, 2023

Conditions

DiabetesInflammation

Keywords

DiabetesVascular riskInflammation

Outcome Measures

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

    2 years

Study Arms (3)

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

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient with diabetes or healthy individuals

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Diabetes MellitusInflammation

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer Larsen, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 24, 2007

Study Start

April 25, 2007

Primary Completion

March 29, 2018

Study Completion

March 29, 2018

Last Updated

September 14, 2023

Record last verified: 2023-09

Locations

US(1)