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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 Insulin Pump | Patients with type 1 diabetes starting insulin pump treatment |
| |
| Type 1 conventional therapy | Patients with type 1 diabetes continuing treatment with 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. |
| |
| 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. |
| |
| 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. |
| |
| Healthy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin pump | Other | Insulin pump therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in dark adaptation kinetics and threshold values, amplitudes/implicit times, retinal vessel diameters, perfusion velocity and oximetry. | 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 | Baseline, 1 week, 1 month, 4 months, 7 months, 12 months, 18 months, 24 months, 42 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oliver Klefter, MD | Contact | +45 38 63 48 18 |
| Name | Affiliation | Role |
|---|---|---|
| Oliver Klefter, MD | Glostrup UH | Principal Investigator |
| Michael Larsen, Professor, DMSci | Glostrup UH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Glostrup Hospital | Recruiting | Glostrup Municipality | 2600 | Denmark |
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Healthy volunteers.
| Multiple daily insulin injections | Other | Multiple daily insulin injections |
|
| Bariatric surgery | Procedure | Pre-operative weight loss and bariatric surgery. |
|
| Medical therapy for type 2 diabetes | Other | Medical glucose-lowering therapy and non-surgical weight-lowering interventions. |
|
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
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| ID | Term |
|---|---|
| D007332 | Insulin Infusion Systems |
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007260 | Infusion Pumps |
| D004864 | Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013514 | Surgical Procedures, Operative |
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