Retinal Adaptation to Intensified Insulin Therapy and Bariatric Surgery in Patients With Diabetes

• Conditions: Diabetes Mellitus; Diabetic Retinopathy
• Interventions: Other: Insulin pump; Other: Multiple daily insulin injections; Procedure: Bariatric surgery; Other: Medical therapy for type 2 diabetes

• Registration Number: NCT01517490
• Lead Sponsor: Glostrup University Hospital, Copenhagen

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-25
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-11
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with type 1 diabetes and suboptimal metabolic regulation.
• Patients with type 2 diabetes and suboptimal metabolic regulation.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 1 Insulin Pump	Insulin pump	Patients with type 1 diabetes starting insulin pump treatment
Type 1 conventional therapy	Multiple daily insulin injections	Patients with type 1 diabetes continuing treatment with multiple daily insulin injections.
Type 2 Bariatric surgery	Bariatric surgery	Patients with type 2 diabetes who are enrolled in pre-operative weight loss protocol prior to bariatric surgery.
Type 2 conventional	Medical therapy for type 2 diabetes	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	Insulin pump	Patients with type 1 diabetes previously followed in an observational study with electrophysiological and psychophysical measures of retinal function.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Ophthalmology, Glostrup Hospital; 🇩🇰 Glostrup, Denmark