The Retinal Function in Relation to Glucose Changes
1 other identifier
interventional
80
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes
Started Sep 2009
Shorter than P25 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 8, 2009
CompletedFirst Posted
Study publicly available on registry
September 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedSeptember 24, 2009
September 1, 2009
1 month
September 8, 2009
September 23, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in amplitude/implicit times, changes in dark adaptation, changes in vessel caliber, changes in Optical coherence tomography (OCT)
1 day
Study Arms (1)
Glucose
OTHERSubjects are given an oral glucose tolerance test.
Interventions
Subjects ingest an oral glucose tolerance test.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Test individuals with significant cataract, prior surgery to the eye, diabetic retinopathy, other serious eye disease, hypertension, other serious systemic disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Glostrup Hospital
Glostrup Municipality, 2600, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stig Holfort, Medical Doctor
Glostrup University Hospital, Copenhagen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 8, 2009
First Posted
September 9, 2009
Study Start
September 1, 2009
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
September 24, 2009
Record last verified: 2009-09