Diabetes MellitusNCT01517490
Retinal Adaptation to Intensified Insulin Therapy and Bariatric Surgery in Patients With Diabetes
An observational study of Diabetes Mellitus and Diabetic Retinopathy, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
Retinal function is highly dependent on the glucose supply. Thus, functional adaptations occur in response to both acute and long-term changes in glycaemia. The purpose of this study is to examine functional and metabolic aspects of retinal adaptation to long-lasting changes in glycaemic control in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetic Retinopathy
- What is being tested?
- Insulin pump, Multiple daily insulin injections and Bariatric surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2011to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 patients with type 1 diabetes and suboptimal metabolic regulation which is to be optimized by insulin pump therapy. 30 patients with type 1 diabetes and suboptimal metabolic regulation in whom insulin pump therapy is not planned. 20 patients with type 2 diabetes and suboptimal metabolic regulation who are enrolled in a pre-operative weight lowering protocol prior to bariatric surgery. 20 patients with type 2 diabetes and suboptimal metabolic regulation who are not enrolled in treatment protocols relating to bariatric surgery. 17 patients with type 1 diabetes on insulin pump therapy who were previously followed in an observational study of retinal function.
Who may be able to join
- Patients with type 1 diabetes and suboptimal metabolic regulation.
- Patients with type 2 diabetes and suboptimal metabolic regulation.
Who cannot join
- Significant cataract
- Glaucoma
- Proliferative diabetic retinopathy fulfilling ETDRS treatment criteria.
- Clinically significant macular edema fulfilling ETDRS treatment criteria.
- Age-related macular degeneration
- Prior surgery to the eye
- Other serious eye disease
- Hypertension
Trial locations and contacts
1 site in 1 country.
Oliver Klefter, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, Glostrup Hospital
Glostrup Municipality, 2600
Oliver Klefter, MD, +45 38 63 48 18, oliver.niels@gmail.com
Michael Larsen, Professor, DMSci, +45 38 63 48 34
About this study
Retinal function is highly dependent on the glucose supply. Thus, functional adaptations occur in response to both acute and long-term changes in glycaemia.
The purpose of this study is to examine functional and metabolic aspects of retinal adaptation to long-lasting changes in glycaemic control in patients with diabetes. The adaptational phenomena will be characterized by electroretinography, dark adaptation, measures of retinal perfusion and oximetry as well as diabetic retinopathy grading and (OCT).
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy
- Being tested
- Insulin pump, Multiple daily insulin injections, Bariatric surgery, Medical therapy for type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin pumpOther
Insulin pump therapy
Multiple daily insulin injectionsOther
Multiple daily insulin injections
Bariatric surgeryProcedure or surgery
Pre-operative weight loss and bariatric surgery.
Medical therapy for type 2 diabetesOther
Medical glucose-lowering therapy and non-surgical weight-lowering interventions.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 Insulin Pump | Patients with type 1 diabetes starting insulin pump treatment Receives: Other: Insulin pump | |
| Type 1 conventional therapy | Patients with type 1 diabetes continuing treatment with multiple daily insulin injections. Receives: Other: Multiple daily insulin injections | |
| Type 2 Bariatric surgery | Patients with type 2 diabetes who are enrolled in pre-operative weight loss protocol prior to bariatric surgery. Receives: Procedure: Bariatric surgery | |
| Type 2 conventional | Severely obese patients with type 2 diabetes who are to continue with non-surgical treatments of diabetes and obesity and with no planned bariatric surgery. Receives: Other: Medical therapy for type 2 diabetes | |
| Type 1 insulin pumpe follow-up | Patients with type 1 diabetes previously followed in an observational study with electrophysiological and psychophysical measures of retinal function. Receives: Other: Insulin pump | |
| Healthy | Healthy volunteers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in dark adaptation kinetics and threshold values, amplitudes/implicit times, retinal vessel diameters, perfusion velocity and oximetry.
Measured: Baseline, 1 week, 1 month, 4 months, 7 months, 12 months, 18 months, 24 months, 42 months
Changes in visual acuity, diabetic retinopathy grading and OCT
Measured: Baseline, 1 week, 1 month, 4 months, 7 months, 12 months, 18 months, 24 months, 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startAug 2011
- Primary completionDec 2016 (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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliver Niels Klefter, Glostrup University Hospital, Copenhagen
- Investigators
- Oliver Klefter, MD, Principal investigator, Glostrup UHMichael Larsen, Professor, DMSci, Study director, Glostrup UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517490
- Sponsor's protocol ID
- Klefter1
- Status last verified
- Mar 2015
- First submitted
- 23 Jan 2012
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Adaptation to Intensified Insulin Therapy and Bariatric Surgery in Patients With Diabetes
- ClinicalTrials.gov ID
- NCT01517490
- Acronym / sponsor ID
- Klefter1
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2016 (estimated)
- First posted
- 25 Jan 2012 (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.
Retinal function is highly dependent on the glucose supply. Thus, functional adaptations occur in response to both acute and long-term changes in glycaemia.
The purpose of this study is to examine functional and metabolic aspects of retinal adaptation to long-lasting changes in glycaemic control in patients with diabetes. The adaptational phenomena will be characterized by electroretinography, dark adaptation, measures of retinal perfusion and oximetry as well as diabetic retinopathy grading and (OCT).
Study design
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Type 1 Insulin Pump | – | Other: Insulin pumpPatients with type 1 diabetes starting insulin pump treatment |
| Type 1 conventional therapy | – | Other: Multiple daily insulin injectionsPatients with type 1 diabetes continuing treatment with multiple daily insulin injections. |
| Type 2 Bariatric surgery | – | Procedure: Bariatric surgeryPatients with type 2 diabetes who are enrolled in pre-operative weight loss protocol prior to bariatric surgery. |
| Type 2 conventional | – | Other: Medical therapy for type 2 diabetesSeverely obese patients with type 2 diabetes who are to continue with non-surgical treatments of diabetes and obesity and with no planned bariatric surgery. |
| Type 1 insulin pumpe follow-up | – | Other: Insulin pumpPatients with type 1 diabetes previously followed in an observational study with electrophysiological and psychophysical measures of retinal function. |
| Healthy | – | –Healthy volunteers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients with type 1 diabetes and suboptimal metabolic regulation which is to be optimized by insulin pump therapy. 30 patients with type 1 diabetes and suboptimal metabolic regulation in whom insulin pump therapy is not planned. 20 patients with type 2 diabetes and suboptimal metabolic regulation who are enrolled in a pre-operative weight lowering protocol prior to bariatric surgery. 20 patients with type 2 diabetes and suboptimal metabolic regulation who are not enrolled in treatment protocols relating to bariatric surgery. 17 patients with type 1 diabetes on insulin pump therapy who were previously followed in an observational study of retinal function.
Key inclusion criteria (2 listed)
- Patients with type 1 diabetes and suboptimal metabolic regulation.
- Patients with type 2 diabetes and suboptimal metabolic regulation.
Key exclusion criteria (8 listed)
- Significant cataract
- Glaucoma
- Proliferative diabetic retinopathy fulfilling ETDRS treatment criteria.
- Clinically significant macular edema fulfilling ETDRS treatment criteria.
- Age-related macular degeneration
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 pumpInsulin pump therapy | Other | Type 1 Insulin Pump, Type 1 insulin pumpe follow-up |
| Multiple daily insulin injectionsMultiple daily insulin injections | Other | Type 1 conventional therapy |
| Bariatric surgeryPre-operative weight loss and bariatric surgery. | Procedure or surgery | Type 2 Bariatric surgery |
| Medical therapy for type 2 diabetesMedical glucose-lowering therapy and non-surgical weight-lowering interventions. | Other | Type 2 conventional |
Primary outcome
Changes in dark adaptation kinetics and threshold values, amplitudes/implicit times, retinal vessel diameters, perfusion velocity and oximetry.
Time frame: Baseline, 1 week, 1 month, 4 months, 7 months, 12 months, 18 months, 24 months, 42 months
Changes in visual acuity, diabetic retinopathy grading and OCT
Time frame: Baseline, 1 week, 1 month, 4 months, 7 months, 12 months, 18 months, 24 months, 42 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
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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.
Oliver Klefter, MD contact
Oliver Klefter, MD principal investigator
Glostrup UH
Michael Larsen, Professor, DMSci study director
Glostrup UH
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 and Diabetic Retinopathy, 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 2 inclusion and 8 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 11 Mar 2015. 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 Oliver Klefter, MD (+45 38 63 48 18), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in dark adaptation kinetics and threshold values, amplitudes/implicit times, retinal vessel diameters, perfusion velocity and oximetry. (time frame: Baseline, 1 week, 1 month, 4 months, 7 months, 12 months, 18 months, 24 months, 42 months). The study lists 2 primary outcomes in all. 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 11 Mar 2015.