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

Glostrup University Hospital, Copenhagen

Status: Unknown

Conditions: Diabetes Mellitus; Diabetic Retinopathy

Treatments: Other: Medical therapy for type 2 diabetes; Procedure: Bariatric surgery; Other: Insulin pump; Other: Multiple daily insulin injections

Study type: Observational

Funder types: Other

Identifiers

NCT01517490

Klefter1

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 6 patient groups

Type 1 Insulin Pump

Description:

Patients with type 1 diabetes starting insulin pump treatment

Treatment:

Other: Insulin pump

Type 1 conventional therapy

Description:

Patients with type 1 diabetes continuing treatment with multiple daily insulin injections.

Treatment:

Other: Multiple daily insulin injections

Type 2 Bariatric surgery

Description:

Patients with type 2 diabetes who are enrolled in pre-operative weight loss protocol prior to bariatric surgery.

Treatment:

Procedure: Bariatric surgery

Type 2 conventional

Description:

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.

Treatment:

Other: Medical therapy for type 2 diabetes

Type 1 insulin pumpe follow-up

Description:

Patients with type 1 diabetes previously followed in an observational study with electrophysiological and psychophysical measures of retinal function.

Treatment:

Other: Insulin pump

Healthy

Description:

Healthy volunteers.