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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Glostrup University Hospital, Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00973401
First received: September 8, 2009
Last updated: September 23, 2009
Last verified: September 2009
History of Changes
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Stig Holfort, Glostrup Hospital, department of Ophthalmology
ClinicalTrials.gov Identifier: NCT00973401     History of Changes
Other Study ID Numbers: Holfort
Study First Received: September 8, 2009
Last Updated: September 23, 2009
Health Authority: Denmark: National Board of Health

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

ClinicalTrials.gov processed this record on May 21, 2013