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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01517490
• Other study ID #: Klefter1
• Status: Recruiting
• Phase: N/A
• First received: January 23, 2012
• Last updated: March 10, 2015
• Start date: August 2011

Study information

• Verified date: March 2015
• Source: Glostrup University Hospital, Copenhagen
• Contact: Oliver Klefter, MD
• Phone: +45 38 63 48 18
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Retinopathy

Intervention

Other:
• Insulin pump
Insulin pump therapy
• Multiple daily insulin injections
Multiple daily insulin injections

Procedure:
• Bariatric surgery
Pre-operative weight loss and bariatric surgery.

Other:
• Medical therapy for type 2 diabetes
Medical glucose-lowering therapy and non-surgical weight-lowering interventions.

Locations

Country	Name	City	State
Denmark	Department of Ophthalmology, Glostrup Hospital	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No