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

This study has been completed.
Sponsor:
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01136902
First received: June 1, 2010
Last updated: December 7, 2010
Last verified: December 2010
History of Changes
  Purpose

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 Intervention
Diabetes Mellitus
 Dietary Supplement: Oral Glucose Tolerance Test (OGTT)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measuring Retinal Vessel Caliber in Relation to Dark Adaptation and Blood Glucose Level

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Vessel caliber [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood glucose level [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Enrollment: 14
Study Start Date: August 2009
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   17 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136902

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

No publications provided

Responsible Party: Stig Holfort, MD, Glostrup University Hospital,Copenhagen
ClinicalTrials.gov Identifier: NCT01136902     History of Changes
Other Study ID Numbers: Kappelgaard, vessel
Study First Received: June 1, 2010
Last Updated: December 7, 2010
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013