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

This study is currently recruiting participants.
Verified November 2012 by Glostrup University Hospital, Copenhagen
Sponsor:
Information provided by (Responsible Party):
Oliver Niels Klefter, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01517490
First received: January 23, 2012
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

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).


Condition Intervention
Diabetes Mellitus
Diabetic Retinopathy
 Other: Insulin pump
Other: Multiple daily insulin injections
Procedure: Bariatric surgery
Other: Medical therapy for type 2 diabetes

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Retinal Adaptation to Intensified Insulin Therapy and Bariatric Surgery in Patients With Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517490

Contacts
Contact: Oliver Klefter, MD +45 38 63 48 18

Locations
Denmark
Department of Ophthalmology, Glostrup Hospital Recruiting
Glostrup, Denmark, 2600
Contact: Oliver Klefter, MD     +45 38 63 48 18     oliver.niels@gmail.com    
Contact: Michael Larsen, Professor, DMSci     +45 38 63 48 34        
Principal Investigator: Oliver Klefter, MD            
Principal Investigator: Michael Larsen, Professor, DMSci            
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
Principal Investigator: Oliver Klefter, MD Glostrup UH
Study Director: Michael Larsen, Professor, DMSci Glostrup UH
  More Information

No publications provided

Responsible Party: Oliver Niels Klefter, Principal Investigator, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01517490     History of Changes
Other Study ID Numbers: Klefter1
Study First Received: January 23, 2012
Last Updated: November 1, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Retinopathy
Retinal Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Eye Diseases
Diabetic Angiopathies
 Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013