Skip to main content
OpenTrials
Completed

NCT Number: NCT01136902

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

17 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen University Hospital at Glostrup

Copenhagen, DK-2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Glucose Tolerance Test (OGTT)

Dietary Supplement

75 g of glucose dissolved in 250 mL water.

Other names: OGTT

Primary outcomes

  1. Vessel caliber

    Time frame: 1 day

Secondary outcomes

  1. Blood glucose level

    Time frame: 1 day

    Capillary samples.

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 4, 2010
Registry last updated
Dec 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.