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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by Glostrup University Hospital, Copenhagen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00973401
First Posted: September 9, 2009
Last Update Posted: September 24, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Glostrup University Hospital, Copenhagen
  Purpose
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 Intervention
Diabetes Mellitus Other: Insulin pump

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Glostrup University Hospital, Copenhagen:

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

Estimated Enrollment: 30
Study Start Date: September 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Diabetic individuals Other: Insulin pump
Patients receive an insulin pump that optimizes their glucose control.

  Eligibility

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.
  Contacts and Locations
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
  More Information

Responsible Party: Stig Holfort, Glostrup Hospital, department of Ophthalmology
ClinicalTrials.gov Identifier: NCT00973401     History of Changes
Other Study ID Numbers: Holfort
First Submitted: September 8, 2009
First Posted: September 9, 2009
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