NCT01517490|Unknown
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Sponsor study identifier
observational
100
1 country
1
Study Start
August 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
Not reported
Date not reportedRetinal 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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2011
Date type not reportedThis date has not been verified as actual or estimated.
January 23, 2012
Actual (reported)January 25, 2012
Actual (reported)December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Patients with type 1 diabetes starting insulin pump treatment
Patients with type 1 diabetes continuing treatment with multiple daily insulin injections.
Patients with type 2 diabetes who are enrolled in pre-operative weight loss protocol prior to bariatric surgery.
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.
Patients with type 1 diabetes previously followed in an observational study with electrophysiological and psychophysical measures of retinal function.
Insulin pump therapy
Multiple daily insulin injections
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.
Department of Ophthalmology, Glostrup Hospital
Glostrup Municipality, 2600, Denmark
Oliver Klefter, MD
Glostrup UH
Michael Larsen, Professor, DMSci
Glostrup UH
First Submitted
January 23, 2012
First Posted
January 25, 2012
Study Start
August 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Estimated (date passed)Sorbinil Retinopathy Trial (SRT)
Healthy volunteers.
Pre-operative weight loss and bariatric surgery.
Medical glucose-lowering therapy and non-surgical weight-lowering interventions.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 11, 2015
Record last verified: 2015-03
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Source: ClinicalTrials.gov.
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