Skip to content

The Retinal Function in Relation to Glucose Changes

The Retinal Function in Relation to Glucose Changes

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00973726
Enrollment
80
Registered
2009-09-09
Start date
2009-09-30
Completion date
2009-10-31
Last updated
2009-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Brief summary

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

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.

Interventions

OTHERGlucose test

Subjects ingest an oral glucose tolerance test.

Sponsors

Glostrup University Hospital, Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Changes in amplitude/implicit times, changes in dark adaptation, changes in vessel caliber, changes in Optical coherence tomography (OCT)1 day

Countries

Denmark

Contacts

Primary ContactStig Holfort, Medical Doctor
+4551948354

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026