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

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ClinicalTrials.gov Identifier: NCT00973401
Recruitment Status : Unknown
Verified September 2009 by Glostrup University Hospital, Copenhagen.
Recruitment status was:  Recruiting
First Posted : September 9, 2009
Last Update Posted : September 24, 2009
Sponsor:
Information provided by:
Glostrup University Hospital, Copenhagen

Brief Summary:
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.

Condition or disease Intervention/treatment
Diabetes Mellitus Other: Insulin pump

Study Type : Observational
Estimated Enrollment : 30 participants
Time Perspective: Prospective
Study Start Date : September 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Diabetic individuals Other: Insulin pump
Patients receive an insulin pump that optimizes their glucose control.



Primary Outcome Measures :
  1. Changes in amplitude/implicit times, retinal vessel diameter, dark adaptation and OCT [ Time Frame: 1 week, 1 month, 4 months, 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
30 type 1 diabetics without diabetic retinopathy, with dysregulated metabolic status that is to be medically optimized.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00973401


Contacts
Contact: Stig Holfort, medical doctor +4543234817

Locations
Denmark
Glostrup Hospital Recruiting
Glostrup, Denmark, 2600
Contact: Stig Holfort, medical doctor    +4543234817      
Principal Investigator: Stig Holfort, medical doctor         
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen

Responsible Party: Stig Holfort, Glostrup Hospital, department of Ophthalmology
ClinicalTrials.gov Identifier: NCT00973401     History of Changes
Other Study ID Numbers: Holfort
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: September 24, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs