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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01136902
• Other study ID #: Kappelgaard, vessel
• Status: Completed
• Phase: N/A
• First received: June 1, 2010
• Last updated: December 7, 2010
• Start date: August 2009
• Est. completion date: September 2010

Study information

• Verified date: December 2010
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Dietary Supplement:
• Oral Glucose Tolerance Test (OGTT)
75 g of glucose dissolved in 250 mL water.

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital at Glostrup	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vessel caliber		1 day	No
Secondary	Blood glucose level	Capillary samples.	1 day	No