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The overall objective is to investigate, whether retinal blood vessel diameter change during the energy consuming dark adaptation process and if responses vary between low and high blood glucose.
All subjects are being studied using the same procedure. The study schedule takes place from 8 a.m. to 12 a.m. every time. Each subject shows up on one single day. Subjects are to show up fasting overnight with a break in insulin and/or oral antidiabetic treatment.
The study eye of each subject will be selected by randomisation. We seek to have an equal distribution of right and left eyes overall.
A first set of images will be taken after 5 minutes in "standardised daylight", in a room without light from outside, which eliminates any concerns about weather variations. After this the room is completely darkened. 2 set of images will be taken in the dark adapted state after 20 and 40 minutes. Subsequently the patient ingests the OGTT and will reach maximum blood glucose level after about 60-90 minutes. At this time, the subjects undergo the same "photo session" as above with high blood glucose levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 2 DM | This group includes subjects diagnosed with type 2 diabetes mellitus with none or minimal diabetic retinopathy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Glucose Tolerance Test (OGTT) | Dietary Supplement | 75 g of glucose dissolved in 250 mL water. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vessel caliber | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose level | Capillary samples. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with diagnosed Type 2 diabetes mellitus with none or minimal diabetic retinopathy.
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| Name | Affiliation | Role |
|---|---|---|
| Stig K Holfort, MD | Glostrup University Hospital, Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital at Glostrup | Copenhagen | Copenhagen | DK-2600 | Denmark |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D005951 | Glucose Tolerance Test |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Venous blood sample. Na+, K+, Crea, HbA1c. Capillary glucose measurement. Samples will be analysed and destructed according to normal laboratory practice at the Glostrup Hospital.
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |