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The Retinal Function in Relation to Glucose Changes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Glostrup University Hospital, Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00973726
First received: September 8, 2009
Last updated: September 23, 2009
Last verified: September 2009
History of Changes
  Purpose

This project has the following specific purposes:

  • To develop a clinically usable test to determine the blood glucose level or HbA1c-level, to which the retina is adapted. This will be performed by means of ERG implicit time measurements in relation to the blood glucose level during an oral glucose tolerance test (OGTT) and inter- or extrapolation to the level of blood glucose (or HbA1c) where implicit time is normal.
  • To examine darkadaptation in diabetics in relation to changes in the glucose level.
  • To examine vessel diameter changes in diabetic individuals when changing the glucose level transiently

Condition Intervention
Diabetes
 Other: Glucose test

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: The Retinal Function in Relation to Glucose Changes

Resource links provided by NLM:

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

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

Primary Outcome Measures:
  • Changes in amplitude/implicit times, changes in dark adaptation, changes in vessel caliber, changes in Optical coherence tomography (OCT) [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2009
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Glucose
Subjects are given an oral glucose tolerance test.
 Other: Glucose test
Subjects ingest an oral glucose tolerance test.
Other Name: Standardized oral glucose tolereance test (75 g glucose)

Detailed Description:

Study 1: 24 type 2 diabetics with minimal diabetic retinopathy but varying HbA1c level.

Study 2: 24 type 2 diabetics with minimal diabetic retinopathy. Study 3: 24 type 2 diabetics with minimal diabetic retinopathy.

Plan of trial:

Study 1: Test individuals will be examined at baseline: Prior history of illness, eye examination, blood test, fundusphoto and fullfield-ERG. Afterwards test individuals will take an oral glucose tolerance test (OGTT) which results in a peak in blood glucose after approx. 2 hours, whereafter the blood glucose level normalizes. Immediately after the sugar intake test individuals will be examined by repeated fullfield-ERG's and blood glucose measurements (every 30 min) until the blood glucose level has been normalized.

Study 2: Test individuals will be examined at baseline: Prior history of illness, eye examination, blood test, fundusphoto and dark adaptation. Afterwards test individuals will take an oral glucose tolerance test (OGTT) which results in a peak in blood glucose after approx. 2 hours, whereafter the blood glucose level normalizes. 80 minutes after the sugar intake test individuals will be examined by repeated dark adaptation and blood glucose measurements.

Study 3: Test individuals will be examined at baseline: Prior history of illness, eye examination, blood test, fundusphoto. Afterwards test individuals will take an oral glucose tolerance test (OGTT) which results in a peak in blood glucose after approx. 2 hours, whereafter the blood glucose level normalizes. At baseline (fasting) and 80 minutes after the sugar intake test individuals will be examined by redfree photos of optic disc and blood glucose measurements.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetic individuals. Age > 17 < 80
  • Dysregulated type 1 diabetic individuals and newly diagnosed type 1 diabetics. Age >17 < 60 years
  • with 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: NCT00973726

Contacts
Contact: Stig Holfort, Medical Doctor +4551948354

Locations
Denmark
Glostrup Hospital Recruiting
Glostrup, Denmark, 2600
Contact: Stig Holfort, Medical doctor     +45 43234817        
Principal Investigator: Stig Holfort, Medical Doctor            
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
Principal Investigator: Stig Holfort, Medical Doctor Glostrup Hospital
  More Information

No publications provided

Responsible Party: Stig Holfort, Glostrup Hospital, department of Ophthalmology
ClinicalTrials.gov Identifier: NCT00973726     History of Changes
Other Study ID Numbers: Stig Holfort
Study First Received: September 8, 2009
Last Updated: September 23, 2009
Health Authority: Denmark: National Board of Health

ClinicalTrials.gov processed this record on May 19, 2013