Retinal Function in Relation to Long Term Changes in the Glucose Level

NCT ID: NCT00973401

Last Updated: 2009-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-06-30

Brief Summary

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The purpose of this study is to measure the amplitude and implicit time of electroretinogram (ERG), darkadaptation and the calibre of retinal vessels before and after optimized medical treatment of diabetic individuals (a lower blood glucose level) over a period of 12 months. Newly diagnosed type 1 and type 2 diabetics as well as dysregulated type 1 and type 2 diabetic individuals will be included. Retinal vessel calibre measurements will be used as an estimation of changes in the retinal perfusion.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetic individuals

Insulin pump

Intervention Type OTHER

Patients receive an insulin pump that optimizes their glucose control.

Interventions

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Insulin pump

Patients receive an insulin pump that optimizes their glucose control.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Dysregulated type 1 diabetic individuals and newly diagnosed type 1 diabetics. Age \>17 \< 60 years

Exclusion Criteria

* Test individuals with significant cataract, prior surgery to the eye, diabetic retinopathy, other serious eye disease, hypertension, other serious systemic disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Glostrup Hospital, department of Ophthalmology

Locations

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Glostrup Hospital

Glostrup Municipality, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Stig Holfort, medical doctor

Role: CONTACT

+4543234817

Facility Contacts

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Stig Holfort, medical doctor

Role: primary

+4543234817

Other Identifiers

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Holfort

Identifier Type: -

Identifier Source: org_study_id

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