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Clinical Trials/NCT01136902
NCT01136902
Completed
Not Applicable

Measuring Retinal Vessel Caliber in Relation to Dark Adaptation and Blood Glucose Level

Glostrup University Hospital, Copenhagen1 site in 1 country14 target enrollmentAugust 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Glostrup University Hospital, Copenhagen
Enrollment
14
Locations
1
Primary Endpoint
Vessel caliber
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
September 2010
Last Updated
15 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Glostrup University Hospital, Copenhagen

Eligibility Criteria

Inclusion Criteria

  • Type 2 diabetic individuals.
  • minimal or no diabetic retinopathy defined by no more than five microaneurysms or dot hemorrhages per eye on three non-stereoscopic 50 degree color fundus photographs

Exclusion Criteria

  • Test individuals with significant cataract, prior surgery to the eye, diabetic retinopathy, other serious eye disease, hypertension, other serious systemic disease

Outcomes

Primary Outcomes

Vessel caliber

Time Frame: 1 day

Secondary Outcomes

  • Blood glucose level(1 day)

Study Sites (1)

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