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

September 8, 2009
September 23, 2009
September 2009
October 2009   (final data collection date for primary outcome measure)
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 ]
Changes in amplitude/implicit times, changes in dark adaptation, changes in vessel caliber, changes in OCT, [ Time Frame: 1 day, 1 week, 1 month, 4 months, 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00973726 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Retinal Function in Relation to Glucose Changes
The Retinal Function in Relation to Glucose Changes

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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Diabetes
Other: Glucose test
Subjects ingest an oral glucose tolerance test.
Other Name: Standardized oral glucose tolereance test (75 g glucose)
Glucose
Subjects are given an oral glucose tolerance test.
Intervention: Other: Glucose test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
October 2009
October 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact: Stig Holfort, Medical Doctor +4551948354
Denmark
 
NCT00973726
Stig Holfort
Yes
Stig Holfort, Glostrup Hospital, department of Ophthalmology
Glostrup University Hospital, Copenhagen
Not Provided
Principal Investigator: Stig Holfort, Medical Doctor Glostrup Hospital
Glostrup University Hospital, Copenhagen
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP