Retinal Adaptation to Intensified Insulin Therapy and Bariatric Surgery in Patients With Diabetes
NCT ID: NCT01517490
Last Updated: 2015-03-11
Study Results
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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UNKNOWN
100 participants
OBSERVATIONAL
2011-08-31
Brief Summary
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The purpose of this study is to examine functional and metabolic aspects of retinal adaptation to long-lasting changes in glycaemic control in patients with diabetes. The adaptational phenomena will be characterized by electroretinography, dark adaptation, measures of retinal perfusion and oximetry as well as diabetic retinopathy grading and (OCT).
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Study Groups
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Type 1 Insulin Pump
Patients with type 1 diabetes starting insulin pump treatment
Insulin pump
Insulin pump therapy
Type 1 conventional therapy
Patients with type 1 diabetes continuing treatment with multiple daily insulin injections.
Multiple daily insulin injections
Multiple daily insulin injections
Type 2 Bariatric surgery
Patients with type 2 diabetes who are enrolled in pre-operative weight loss protocol prior to bariatric surgery.
Bariatric surgery
Pre-operative weight loss and bariatric surgery.
Type 2 conventional
Severely obese patients with type 2 diabetes who are to continue with non-surgical treatments of diabetes and obesity and with no planned bariatric surgery.
Medical therapy for type 2 diabetes
Medical glucose-lowering therapy and non-surgical weight-lowering interventions.
Type 1 insulin pumpe follow-up
Patients with type 1 diabetes previously followed in an observational study with electrophysiological and psychophysical measures of retinal function.
Insulin pump
Insulin pump therapy
Healthy
Healthy volunteers.
No interventions assigned to this group
Interventions
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Insulin pump
Insulin pump therapy
Multiple daily insulin injections
Multiple daily insulin injections
Bariatric surgery
Pre-operative weight loss and bariatric surgery.
Medical therapy for type 2 diabetes
Medical glucose-lowering therapy and non-surgical weight-lowering interventions.
Eligibility Criteria
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Inclusion Criteria
* Patients with type 2 diabetes and suboptimal metabolic regulation.
Exclusion Criteria
* Glaucoma
* Proliferative diabetic retinopathy fulfilling ETDRS treatment criteria.
* Clinically significant macular edema fulfilling ETDRS treatment criteria.
* Age-related macular degeneration
* Prior surgery to the eye
* Other serious eye disease
* Hypertension
18 Years
ALL
No
Sponsors
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Glostrup University Hospital, Copenhagen
OTHER
Responsible Party
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Oliver Niels Klefter
Principal Investigator
Principal Investigators
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Oliver Klefter, MD
Role: PRINCIPAL_INVESTIGATOR
Glostrup UH
Michael Larsen, Professor, DMSci
Role: STUDY_DIRECTOR
Glostrup UH
Locations
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Department of Ophthalmology, Glostrup Hospital
Glostrup Municipality, , Denmark
Countries
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Central Contacts
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Oliver Klefter, MD
Role: CONTACT
Facility Contacts
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Michael Larsen, Professor, DMSci
Role: backup
Other Identifiers
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Klefter1
Identifier Type: -
Identifier Source: org_study_id
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