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

NCT ID: NCT01136902

Last Updated: 2010-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus

Keywords

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Diabetes Mellitus Retinal Vessels Physiology

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Type 2 DM

This group includes subjects diagnosed with type 2 diabetes mellitus with none or minimal diabetic retinopathy.

Oral Glucose Tolerance Test (OGTT)

Intervention Type DIETARY_SUPPLEMENT

75 g of glucose dissolved in 250 mL water.

Interventions

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Oral Glucose Tolerance Test (OGTT)

75 g of glucose dissolved in 250 mL water.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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OGTT

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Glostrup University Hospital,Copenhagen

Principal Investigators

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Stig K Holfort, MD

Role: PRINCIPAL_INVESTIGATOR

Glostrup University Hospital, Copenhagen

Locations

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Copenhagen University Hospital at Glostrup

Copenhagen, Copenhagen, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Kappelgaard, vessel

Identifier Type: -

Identifier Source: org_study_id