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

March 10, 2015 updated by: Oliver Niels Klefter, Glostrup University Hospital, Copenhagen

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark, 2600
        • Recruiting
        • Department of Ophthalmology, Glostrup Hospital
        • Contact:
        • Contact:
          • Michael Larsen, Professor, DMSci
          • Phone Number: +45 38 63 48 34
        • Principal Investigator:
          • Oliver Klefter, MD
        • Principal Investigator:
          • Michael Larsen, Professor, DMSci

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Type 1 Insulin Pump
Patients with type 1 diabetes starting insulin pump treatment
Other: Insulin pump
Insulin pump therapy
Type 1 conventional therapy
Patients with type 1 diabetes continuing treatment with multiple daily insulin injections.
Other: Multiple daily insulin injections
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.
Procedure: Bariatric surgery
Pre-operative weight loss and 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.
Other: Medical therapy for type 2 diabetes
Medical glucose-lowering therapy and non-surgical weight-lowering interventions.
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.
Other: Insulin pump
Insulin pump therapy
Healthy
Healthy volunteers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in dark adaptation kinetics and threshold values, amplitudes/implicit times, retinal vessel diameters, perfusion velocity and oximetry.
Time Frame: Baseline, 1 week, 1 month, 4 months, 7 months, 12 months, 18 months, 24 months, 42 months
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
Time Frame: Baseline, 1 week, 1 month, 4 months, 7 months, 12 months, 18 months, 24 months, 42 months
Baseline, 1 week, 1 month, 4 months, 7 months, 12 months, 18 months, 24 months, 42 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glostrup University Hospital, Copenhagen

Investigators

  • Principal Investigator: Oliver Klefter, MD, Glostrup UH
  • Study Director: Michael Larsen, Professor, DMSci, Glostrup UH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

January 23, 2012

First Submitted That Met QC Criteria

January 24, 2012

First Posted (Estimate)

January 25, 2012

Study Record Updates

Last Update Posted (Estimate)

March 11, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Klefter1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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