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CompletedNCT01136902Updated Dec 8, 2010

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

An observational study in Diabetes Mellitus, sponsored by Glostrup University Hospital, Copenhagen. Completed at 1 site in Denmark. Open to participants aged 17 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-12-08.

Sponsored by Glostrup University Hospital, Copenhagen · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
14
Ages
17 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus

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Keywords

  • Diabetes Mellitus
  • Retinal Vessels
  • Physiology
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 14 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Glostrup University Hospital, Copenhagen is the lead sponsor of 104 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects with diagnosed Type 2 diabetes mellitus with none or minimal diabetic retinopathy.

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

Exclusion Criteria:

  • Test individuals with significant cataract, prior surgery to the eye, diabetic retinopathy, other serious eye disease, hypertension, other serious systemic disease
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
14 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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)

Interventions

  • Dietary supplementOral Glucose Tolerance Test (OGTT)

    75 g of glucose dissolved in 250 mL water.

    Also known as: OGTT

06

What researchers measure

Primary outcomes

  1. Vessel caliber

    Time frame: 1 day

Secondary outcomes

  1. Blood glucose level

    Capillary samples.

    Time frame: 1 day

07

Study locations

1 site
  • Copenhagen University Hospital at Glostrup
    Copenhagen, DK-2600, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01136902
Lead sponsor
Glostrup University Hospital, Copenhagen
First posted
Jun 4, 2010
Start date
Aug 2009
Primary completion
Jun 2010
Completion
Sep 2010
Last update
Dec 8, 2010

Study contacts

Stig K Holfort, MD
principal investigator · Glostrup University Hospital, Copenhagen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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