Retinal Adaptation to Intensified Insulin Therapy and Bariatric Surgery in Patients With Diabetes
1 other identifier
observational
100
1 country
1
Brief Summary
Retinal function is highly dependent on the glucose supply. Thus, functional adaptations occur in response to both acute and long-term changes in glycaemia. 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).
Trial Health
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 23, 2012
CompletedFirst Posted
Study publicly available on registry
January 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedMarch 11, 2015
March 1, 2015
5.3 years
January 23, 2012
March 10, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Changes in dark adaptation kinetics and threshold values, amplitudes/implicit times, retinal vessel diameters, perfusion velocity and oximetry.
Baseline, 1 week, 1 month, 4 months, 7 months, 12 months, 18 months, 24 months, 42 months
Changes in visual acuity, diabetic retinopathy grading and OCT
Baseline, 1 week, 1 month, 4 months, 7 months, 12 months, 18 months, 24 months, 42 months
Study Arms (6)
Type 1 Insulin Pump
Patients with type 1 diabetes starting insulin pump treatment
Type 1 conventional therapy
Patients with type 1 diabetes continuing treatment with 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.
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.
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.
Healthy
Healthy volunteers.
Interventions
Medical glucose-lowering therapy and non-surgical weight-lowering interventions.
Eligibility Criteria
30 patients with type 1 diabetes and suboptimal metabolic regulation which is to be optimized by insulin pump therapy. 30 patients with type 1 diabetes and suboptimal metabolic regulation in whom insulin pump therapy is not planned. 20 patients with type 2 diabetes and suboptimal metabolic regulation who are enrolled in a pre-operative weight lowering protocol prior to bariatric surgery. 20 patients with type 2 diabetes and suboptimal metabolic regulation who are not enrolled in treatment protocols relating to bariatric surgery. 17 patients with type 1 diabetes on insulin pump therapy who were previously followed in an observational study of retinal function.
You may qualify if:
- Patients with type 1 diabetes and suboptimal metabolic regulation.
- Patients with type 2 diabetes and suboptimal metabolic regulation.
You may not qualify if:
- Significant cataract
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Ophthalmology, Glostrup Hospital
Glostrup Municipality, 2600, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver Klefter, MD
Glostrup UH
- STUDY DIRECTOR
Michael Larsen, Professor, DMSci
Glostrup UH
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 23, 2012
First Posted
January 25, 2012
Study Start
August 1, 2011
Primary Completion
December 1, 2016
Last Updated
March 11, 2015
Record last verified: 2015-03