Diabetes MellitusNCT00973401
Retinal Function in Relation to Long Term Changes in the Glucose Level
An observational study of Diabetes Mellitus, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to measure the amplitude and implicit time of electroretinogram (ERG), darkadaptation and the calibre of retinal vessels before and after optimized medical treatment of diabetic individuals (a lower blood glucose level) over a period of 12 months. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Insulin pump
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2009to Jun 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 30 type 1 diabetics without diabetic retinopathy, with dysregulated metabolic status that is to be medically optimized.
Who may be able to join
- Dysregulated type 1 diabetic individuals and newly diagnosed type 1 diabetics. Age >17 < 60 years
Who cannot join
- Test individuals with significant cataract, prior surgery to the eye, diabetic retinopathy, other serious eye disease, hypertension, other serious systemic disease.
Trial locations and contacts
1 site in 1 country.
Stig Holfort, medical doctor contact
Denmark1 site, 1 recruiting
- Recruiting
Glostrup Hospital
Glostrup Municipality, 2600
Stig Holfort, medical doctor, +4543234817
Stig Holfort, medical doctor
About this study
The purpose of this study is to measure the amplitude and implicit time of electroretinogram (ERG), darkadaptation and the calibre of retinal vessels before and after optimized medical treatment of diabetic individuals (a lower blood glucose level) over a period of 12 months. Newly diagnosed type 1 and type 2 diabetics as well as dysregulated type 1 and type 2 diabetic individuals will be included. Retinal vessel calibre measurements will be used as an estimation of changes in the retinal perfusion.
- Conditions
- Diabetes Mellitus
- Being tested
- Insulin pump
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin pumpOther
Patients receive an insulin pump that optimizes their glucose control.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic individuals | Not described Receives: Other: Insulin pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in amplitude/implicit times, retinal vessel diameter, dark adaptation and OCT
Measured: 1 week, 1 month, 4 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973401
- Sponsor's protocol ID
- Holfort
- Status last verified
- Sep 2009
- First submitted
- 8 Sep 2009
- Last updated
- 24 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Function in Relation to Long Term Changes in the Glucose Level
- ClinicalTrials.gov ID
- NCT00973401
- Acronym / sponsor ID
- Holfort
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 9 Sep 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.
The purpose of this study is to measure the amplitude and implicit time of electroretinogram (ERG), darkadaptation and the calibre of retinal vessels before and after optimized medical treatment of diabetic individuals (a lower blood glucose level) over a period of 12 months. Newly diagnosed type 1 and type 2 diabetics as well as dysregulated type 1 and type 2 diabetic individuals will be included. Retinal vessel calibre measurements will be used as an estimation of changes in the retinal perfusion.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic individuals | – | Other: Insulin pump |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 30 type 1 diabetics without diabetic retinopathy, with dysregulated metabolic status that is to be medically optimized.
Key inclusion criteria (1 listed)
- Dysregulated type 1 diabetic individuals and newly diagnosed type 1 diabetics. Age >17 < 60 years
Key exclusion criteria (1 listed)
- Test individuals with significant cataract, prior surgery to the eye, diabetic retinopathy, other serious eye disease, hypertension, other serious systemic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin pumpPatients receive an insulin pump that optimizes their glucose control. | Other | Diabetic individuals |
Primary outcome
Changes in amplitude/implicit times, retinal vessel diameter, dark adaptation and OCT
Time frame: 1 week, 1 month, 4 months, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2009.
Related trials for Diabetes Mellitus
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 4
INfluenza VaccInation To Mitigate typE 1 Diabetes
Diabetes Mellitus, Type 1
RecruitingPhase 4
Cholesterol Lowering and Residual Risk in Diabetes, Type 1
Type 1 Diabetes
Recruiting
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Diabetes, End Stage Renal Disease
Recruiting
Effects of Medisinstart for Type 2 Diabetes
Type 2 Diabetes
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.
Stig Holfort, medical doctor contact
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 Mellitus, run by Glostrup University Hospital, Copenhagen 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: status not confirmed, as of the sponsor's last update on 24 Sep 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stig Holfort, medical doctor (+4543234817), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in amplitude/implicit times, retinal vessel diameter, dark adaptation and OCT (time frame: 1 week, 1 month, 4 months, 1 year). 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 24 Sep 2009; AzTrials last refreshed its copy on 29 Oct 2026.