Measuring Retinal Vessel Caliber in Relation to Dark Adaptation and Blood Glucose Level
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|ClinicalTrials.gov Identifier: NCT01136902|
Recruitment Status : Completed
First Posted : June 4, 2010
Last Update Posted : December 8, 2010
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus||Dietary Supplement: Oral Glucose Tolerance Test (OGTT)|
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.
|Study Type :||Observational|
|Actual Enrollment :||14 participants|
|Official Title:||Measuring Retinal Vessel Caliber in Relation to Dark Adaptation and Blood Glucose Level|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||September 2010|
Type 2 DM
This group includes subjects diagnosed with type 2 diabetes mellitus with none or minimal diabetic retinopathy.
Dietary Supplement: Oral Glucose Tolerance Test (OGTT)
75 g of glucose dissolved in 250 mL water.
Other Name: OGTT
- Vessel caliber [ Time Frame: 1 day ]
- Blood glucose level [ Time Frame: 1 day ]Capillary samples.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136902
|Copenhagen University Hospital at Glostrup|
|Copenhagen, Denmark, DK-2600|
|Principal Investigator:||Stig K Holfort, MD||Glostrup University Hospital, Copenhagen|