Type 2 DiabetesNCT01184768
HBA1c and Diagnosis of Type 2 Diabetes
An observational study of Type 2 Diabetes, run by University of Tromso at 1 site in Norway.
Trial summary
Following the 6th Tromso study subjects with HbA1c > 5.7 plus a subsample of subjects with lower hba1c values will be invited to an oral glucose tolerance test to see the predictive value of HBA1c in the diagnosis of type 2 diabetes. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 3,509 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2008to Nov 2010
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: random sample of subjects living in Tromso and who participated in the 6 th Tromsø study
Who may be able to join
- participated in the 6 Tromso study
Who cannot join
- type 2 diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Following the 6th Tromso study subjects with HbA1c > 5.7 plus a subsample of subjects with lower hba1c values will be invited to an oral glucose tolerance test to see the predictive value of HBA1c in the diagnosis of type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, HbA1c, vitamin D, diagnosis
- Medical subject headings
- Diabetes Mellitus, Type 2, Disease
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 |
|---|---|---|
| participants in the 6th tromsø study | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with new diagnosis of type 2 diabetes
Measured: Up to 2 years after participation in the 6th Tromso study
Secondary outcomes (3)
Number of subjects with new diagnosis of impaired glucose tolerance
Measured: Up to 2 years after participation in the 6th Tromso study
Number of subjects with new diagnosis of impaired fasting glucose
Measured: Up to 2 years after participation in the 6th Tromso study
Effect of vitamin D status on glucose tolerance
Measured: Up to 2 years after participation in the 6th Tromso study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startJan 2008
- Primary completionOct 2010
- Study completionNov 2010
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.
- 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
- Cross-sectional
- Enrolment
- 3,509 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Investigators
- rolf jorde, md, Principal investigator, University of Tromso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184768
- Sponsor's protocol ID
- UIT-ENDO-2010-2
- Status last verified
- Jul 2011
- First submitted
- 11 Aug 2010
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HBA1c and Diagnosis of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01184768
- Acronym / sponsor ID
- UIT-ENDO-2010-2
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, HbA1c, vitamin D, diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,509 participants (actual)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 19 Aug 2010 (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.
Following the 6th Tromso study subjects with HbA1c > 5.7 plus a subsample of subjects with lower hba1c values will be invited to an oral glucose tolerance test to see the predictive value of HBA1c in the diagnosis of type 2 diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| participants in the 6th tromsø study | – | – |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- random sample of subjects living in Tromso and who participated in the 6 th Tromsø study
Key inclusion criteria (1 listed)
- participated in the 6 Tromso study
Key exclusion criteria (1 listed)
- type 2 diabetes
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
Number of subjects with new diagnosis of type 2 diabetes
Time frame: Up to 2 years after participation in the 6th Tromso study
3 secondary outcomes
Number of subjects with new diagnosis of impaired glucose tolerance
Time frame: Up to 2 years after participation in the 6th Tromso study
Number of subjects with new diagnosis of impaired fasting glucose
Time frame: Up to 2 years after participation in the 6th Tromso study
Effect of vitamin D status on glucose tolerance
Time frame: Up to 2 years after participation in the 6th Tromso study
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 20 Jul 2011.
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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.
rolf jorde, md principal investigator
University of Tromso
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 Type 2 Diabetes, run by University of Tromso at 1 site in Norway.
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 1 inclusion and 1 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 20 Jul 2011. 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 Norway. 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?
Number of subjects with new diagnosis of type 2 diabetes (time frame: Up to 2 years after participation in the 6th Tromso study). 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 20 Jul 2011; AzTrials last refreshed its copy on 7 Nov 2026.