DiabetesNCT00579228
Vascular Risk Progression in Normal and Diabetic Control Subjects.
An observational study of Diabetes and Inflammation, run by University of Nebraska at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Inflammation
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2007to 29 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any patient with diabetes or healthy individuals
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Vascular Risk Progression in Normal and Diabetes 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.
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.
- Conditions
- Diabetes, Inflammation
- Keywords
- Diabetes, Vascular risk, Inflammation
- Medical subject headings
- Diabetes Mellitus, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study start25 Apr 2007
- Primary completion29 Mar 2018
- Study completion29 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Larsen, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579228
- Sponsor's protocol ID
- 0124-07-EP
- Status last verified
- Sep 2023
- First submitted
- 19 Dec 2007
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Risk Progression in Normal and Diabetes Control Subjects
- ClinicalTrials.gov ID
- NCT00579228
- Acronym / sponsor ID
- 0124-07-EP
- Conditions
- Diabetes, Inflammation
- Keywords
- Diabetes, Vascular risk, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 25 Apr 2007 (actual)
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 24 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient with diabetes or healthy individuals
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Larsen, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Inflammation, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotid intima media measurement change (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.