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

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ClinicalTrials.gov Identifier: NCT01136902
Recruitment Status : Completed
First Posted : June 4, 2010
Last Update Posted : December 8, 2010
Information provided by:
Glostrup University Hospital, Copenhagen

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.

Condition or disease Intervention/treatment
Diabetes Mellitus Dietary Supplement: Oral Glucose Tolerance Test (OGTT)

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.

Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measuring Retinal Vessel Caliber in Relation to Dark Adaptation and Blood Glucose Level
Study Start Date : August 2009
Primary Completion Date : June 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose
U.S. FDA Resources

Group/Cohort Intervention/treatment
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)
75 g of glucose dissolved in 250 mL water.
Other Name: OGTT

Primary Outcome Measures :
  1. Vessel caliber [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Blood glucose level [ Time Frame: 1 day ]
    Capillary samples.

Biospecimen Retention:   Samples Without DNA
Venous blood sample. Na+, K+, Crea, HbA1c. Capillary glucose measurement. Samples will be analysed and destructed according to normal laboratory practice at the Glostrup Hospital.

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136902

Copenhagen University Hospital at Glostrup
Copenhagen, Denmark, DK-2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Principal Investigator: Stig K Holfort, MD Glostrup University Hospital, Copenhagen

Responsible Party: Stig Holfort, MD, Glostrup University Hospital,Copenhagen
ClinicalTrials.gov Identifier: NCT01136902     History of Changes
Other Study ID Numbers: Kappelgaard, vessel
First Posted: June 4, 2010    Key Record Dates
Last Update Posted: December 8, 2010
Last Verified: December 2010

Keywords provided by Glostrup University Hospital, Copenhagen:
Diabetes Mellitus
Retinal Vessels

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucuronyl glucosamine glycan sulfate
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs