Type 1 DiabetesDCPD1987NCT01785667
Incidence of Retinopathy and Associated Risk Factors in Children and Young Adults With Type 1 Diabetes in Denmark
An observational study of Type 1 Diabetes and Diabetic Retinopathy, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The objective of this study is to clarify the current diabetic status, including development of complications, in a nationwide cohort of type 1 diabetics, who were last examined together in a large study in 1995. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Type 1 Diabetes, Diabetic Retinopathy
- How many people
- 132 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2011to Feb 2013
- How long will I take part?
- 16 Years
- 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: This study includes a cohort of type 1 diabetic patients, who originally were identified in 21 paediatric departments and studied in 1986. This group initially consisted of 1033 children and was estimated to involve around 80 percent of all Danish type 1 diabetic patients below the age of 18. In 1995 further examinations were performed on the cohort; this time 339 chose to participate. In this study we will invite the participants from 1995 who also participated in the eye examinations, n=324, to participate in yet another follow-up examination.
Who may be able to join
- Participation in the follow-up study in 1995
Who cannot join
- No retinal photographs from 1995
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Ophthalmology, Odense University Hospital
Odense, Fyn, 5000
About this study
The objective of this study is to clarify the current diabetic status, including development of complications, in a nationwide cohort of type 1 diabetics, who were last examined together in a large study in 1995. These youngsters were originally participating in a nationwide study of children with type 1 diabetes in Denmark back in 1986. The investigators will try to establish risk factors for developing diabetic retinopathy. The investigators will have emphasis on retinal vessel geometry and the possibilities for early detection of reversible retinal changes, and prediction of other vascular complications.
- Conditions
- Type 1 Diabetes, Diabetic Retinopathy
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Retinopathy
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 |
|---|---|---|
| Young Danish adults with type 1 diabetes | This is an observational study with no interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of diabetic retinopathy and proliferative diabetic retinopathy
Using the ETDRS grading protocol the degree of retinopathy in 2011 will be assessed by grading 7-field fundus photographs taken at follow-up examination. This will be related to the degree of retinopathy found in the patients in 1995, where the last study of the cohort took place.
Measured: 16 years
Secondary outcomes (1)
Vessel diameters as a predictor of diabetic retinopathy and proliferative diabetic retinopathy
Using the computer software named IVAN we will assess the average vessel diameters around the optic disc on fundus photos from 1995. This we will relate to the degree of retinopathy in 2011 to see if vessel diameters predicts diabetic eye complications.
Measured: 16 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startJan 2011
- Primary completionNov 2011
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- 132 participants (actual)
- Target duration
- 16 Years
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Eye Research Australia, Moorfields Eye Hospital NHS Foundation Trust
- Responsible party
- Principal investigator, Rebecca Broe Pedersen, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785667
- Sponsor's protocol ID
- S-20100088
- Acronym
- DCPD1987
- Status last verified
- Jul 2014
- First submitted
- 5 Feb 2013
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Retinopathy and Associated Risk Factors in Children and Young Adults With Type 1 Diabetes in Denmark
- ClinicalTrials.gov ID
- NCT01785667
- Acronym / sponsor ID
- DCPD1987 / S-20100088
- Conditions
- Type 1 Diabetes, Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Center for Eye Research Australia, Moorfields Eye Hospital NHS Foundation Trust
- Study start
- Jan 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 7 Feb 2013 (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 objective of this study is to clarify the current diabetic status, including development of complications, in a nationwide cohort of type 1 diabetics, who were last examined together in a large study in 1995. These youngsters were originally participating in a nationwide study of children with type 1 diabetes in Denmark back in 1986. The investigators will try to establish risk factors for developing diabetic retinopathy. The investigators will have emphasis on retinal vessel geometry and the possibilities for early detection of reversible retinal changes, and prediction of other vascular complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 16 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young Danish adults with type 1 diabetes | – | –This is an observational study with no interventions. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study includes a cohort of type 1 diabetic patients, who originally were identified in 21 paediatric departments and studied in 1986. This group initially consisted of 1033 children and was estimated to involve around 80 percent of all Danish type 1 diabetic patients below the age of 18. In 1995 further examinations were performed on the cohort; this time 339 chose to participate. In this study we will invite the participants from 1995 who also participated in the eye examinations, n=324, to participate in yet another follow-up examination.
Key inclusion criteria (1 listed)
- Participation in the follow-up study in 1995
Key exclusion criteria (1 listed)
- No retinal photographs from 1995
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
Incidence of diabetic retinopathy and proliferative diabetic retinopathy
Time frame: 16 years
Using the ETDRS grading protocol the degree of retinopathy in 2011 will be assessed by grading 7-field fundus photographs taken at follow-up examination. This will be related to the degree of retinopathy found in the patients in 1995, where the last study of the cohort took place.
1 secondary outcome
Vessel diameters as a predictor of diabetic retinopathy and proliferative diabetic retinopathy
Time frame: 16 years
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 30 Jul 2014.
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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.
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 1 Diabetes and Diabetic Retinopathy, run by Odense University Hospital at 1 site in Denmark.
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 30 Jul 2014. 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 Denmark. 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?
Incidence of diabetic retinopathy and proliferative diabetic retinopathy (time frame: 16 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 30 Jul 2014.