Type 2 DiabetesNCT00842972
Is Carotid Intima-media Thickness Affected by A1C Variability?
An observational study of Type 2 Diabetes and A1C Variability, run by Yonsei University.
Trial summary
This study was conducted to evaluate the effect of A1C variability on the progression of carotid artery intima-media thickness in type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 34 to 79 years
- Conditions the study is for
- Type 2 Diabetes, A1C Variability
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 34 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: typeII, Fluroscopy in carotid once a year during 2 years.
Who may be able to join
- type II
- fluoroscopy in carotid once a year during 2 years
Who cannot join
- type 1 diabetes
- history or clinical evidence of coronary artery disease or cerebral or peripheral vascular disease
- the presence of albuminuria (defined as 24 hour urine albumin excretion ≥ 30 mg)
- renal dysfunction (defined as creatinine blood level ≥ 2.0 mg/dL)
- hepatic dysfunction (defined as alanine aminotransferase and/or aspartate aminotransferase blood level ≥ 3 × upper normal limit)
- smoking within the past 3 months prior to commencement of the study
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- use of any medication likely to alter IMT such as calcium channel blocker, thiazolidinedione, antiplatelet agent (clopidogrel, cilostazol)
- use of glucocorticoid
- pregnancy
- severe concomitant disease such as cancer
- infection
- Cushing's syndrome
- acromegaly, or any other disorder likely to alter glycemia
- primary hypercholesterolemia
- hypothyroidism or hyperthyroidism
- use of any hormonal drugs
- alcoholism or drug abuse
About this study
This study was conducted to evaluate the effect of A1C variability on the progression of carotid artery intima-media thickness in type 2 diabetic patients.
- Conditions
- Type 2 Diabetes, A1C Variability
- Medical subject headings
- Diabetes Mellitus, Type 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842972
- Sponsor's protocol ID
- 3-2006-0005
- Status last verified
- Sep 2009
- First submitted
- 11 Feb 2009
- Last updated
- 15 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Carotid Intima-media Thickness Affected by A1C Variability?
- ClinicalTrials.gov ID
- NCT00842972
- Acronym / sponsor ID
- 3-2006-0005
- Conditions
- Type 2 Diabetes, A1C Variability
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- First posted
- 12 Feb 2009 (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.
This study was conducted to evaluate the effect of A1C variability on the progression of carotid artery intima-media thickness in type 2 diabetic patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 34 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- typeII, Fluroscopy in carotid once a year during 2 years.
Key inclusion criteria (2 listed)
- type II
- fluoroscopy in carotid once a year during 2 years
Key exclusion criteria (17 listed)
- type 1 diabetes
- history or clinical evidence of coronary artery disease or cerebral or peripheral vascular disease
- the presence of albuminuria (defined as 24 hour urine albumin excretion ≥ 30 mg)
- renal dysfunction (defined as creatinine blood level ≥ 2.0 mg/dL)
- hepatic dysfunction (defined as alanine aminotransferase and/or aspartate aminotransferase blood level ≥ 3 × upper normal limit)
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
Not reported in the source record.
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 15 Sep 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and A1C Variability, run by Yonsei University.
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 2 inclusion and 17 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 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
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 15 Sep 2009.