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

January 23, 2012
November 1, 2012
August 2011
July 2014   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ] [ 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 and 24 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01517490 on ClinicalTrials.gov Archive Site
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Retinal Adaptation to Intensified Insulin Therapy and Bariatric Surgery in Patients With Diabetes
Retinal Adaptation to Intensified Insulin Therapy and Bariatric Surgery in Patients With Diabetes

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).

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Observational
Time Perspective: Prospective
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Non-Probability Sample

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.

  • Diabetes Mellitus
  • Diabetic Retinopathy
  • Other: Insulin pump
    Insulin pump therapy
  • Other: 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.
  • Type 1 Insulin Pump
    Patients with type 1 diabetes starting insulin pump treatment
    Intervention: Other: Insulin pump
  • Type 1 conventional therapy
    Patients with type 1 diabetes continuing treatment with multiple daily insulin injections.
    Intervention: Other: 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.
    Intervention: Procedure: 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.
    Intervention: Other: Medical therapy for type 2 diabetes
  • 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.
    Intervention: Other: Insulin pump
  • Healthy
    Healthy volunteers.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Oliver Klefter, MD +45 38 63 48 18
Denmark
 
NCT01517490
Klefter1
No
Oliver Niels Klefter, Glostrup University Hospital, Copenhagen
Glostrup University Hospital, Copenhagen
Not Provided
Principal Investigator: Oliver Klefter, MD Glostrup UH
Study Director: Michael Larsen, Professor, DMSci Glostrup UH
Glostrup University Hospital, Copenhagen
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP