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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

Tracking Information
First Submitted Date September 8, 2009
First Posted Date September 9, 2009
Last Update Posted Date September 24, 2009
Study Start Date September 2009
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 8, 2009)
Changes in amplitude/implicit times, retinal vessel diameter, dark adaptation and OCT [ Time Frame: 1 week, 1 month, 4 months, 1 year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Retinal Function in Relation to Long Term Changes in the Glucose Level
Official Title Not Provided
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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 30 type 1 diabetics without diabetic retinopathy, with dysregulated metabolic status that is to be medically optimized.
Condition Diabetes Mellitus
Intervention Other: Insulin pump
Patients receive an insulin pump that optimizes their glucose control.
Study Groups/Cohorts Diabetic individuals
Intervention: Other: Insulin pump
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 8, 2009)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2010
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT00973401
Other Study ID Numbers Holfort
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Stig Holfort, Glostrup Hospital, department of Ophthalmology
Study Sponsor Glostrup University Hospital, Copenhagen
Collaborators Not Provided
Investigators Not Provided
PRS Account Glostrup University Hospital, Copenhagen
Verification Date September 2009