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The Relationship Between Stage of Diabetic Retinopathy and Retinal Blood Flow in Patients With IDDM During Euglycemic Clamp

Primary Purpose

Diabetes Mellitus, Type 1, Insulin, Retina

Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Insulin
Glucose
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus, Type 1

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients with IDDM:

  • Age >= 19 years
  • Best corrected visual acuity >= 0.8
  • Ametropia < 6 dpt

Healthy control subjects:

  • Age and sex matched to the subjects in the patients group
  • Best corrected visual acuity >= 0.8
  • Ametropia < 6 dpt

Exclusion Criteria:

Any of the following will exclude a diabetic patient from the study:

  • Presence of intraocular pathology other than diabetic retinopathy (for example: cataract, glaucoma, ocular hypertension)
  • Hypertension (Systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg)
  • Previous laser photocoagulation treatment
  • Pregnancy (in women)

Any of the following will exclude a healthy subject from the study:

  • Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
  • Treatment in the previous 3 weeks with any drug
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
  • Blood donation during the previous 3 weeks
  • Pregnancy (in women)

Sites / Locations

  • Department of Clinical Pharmacology, Medical University of Vienna

Outcomes

Primary Outcome Measures

retinal blood flow after 1 hour of insulin clamp

Secondary Outcome Measures

Mean blood velocities in ophthalmic artery, posterior ciliary arteries and central retinal artery after 1 hour of insulin clamp

Full Information

First Posted
December 22, 2008
Last Updated
December 22, 2008
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00814008
Brief Title
The Relationship Between Stage of Diabetic Retinopathy and Retinal Blood Flow in Patients With IDDM During Euglycemic Clamp
Official Title
The Relationship Between Stage of Diabetic Retinopathy and Retinal Blood Flow in Patients With IDDM During Euglycemic Clamp
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
April 2000 (Actual)
Study Completion Date
December 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

5. Study Description

Brief Summary
Impaired retinal blood flow has been implicated in the pathogenesis of diabetic retinopathy. Patel et al. (1992) showed that retinal blood flow increases with the level of diabetic retinopathy. Grunwald et al. (1996) reported that patients with insulin dependent diabetes mellitus (IDDM) of relatively short duration have increased retinal blood flow, even before the onset of diabetic retinopathy. On the other hand the data of Bursell et al. (1996) indicate that IDDM patients have reduced retinal blood flow, when they have normal blood glucose levels, but this study may have considerable methodological limitations. Acute elevations of blood glucose levels, however, result in an increase in retinal blood flow (Grunwald et al. 1987, Bursell et al. 1996). Based on previous experimental data the investigators hypothesize that ocular blood flow is increased in early diabetes and reduced at later stages of the disease. Previous studies have demonstrated that metabolic conditions such as hyperglycemia influence outcome parameters and thereby might have confounded results regarding ocular blood flow in diabetic retinopathy. The investigators will therefore study patients with IDDM during euglycemic conditions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Insulin, Retina, Regional Blood Flow

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Insulin Dosage form : intravenous infusion, infusion period 60 minutes Dosage: continuous dose of 0.5 mU/kg/min infused intravenously over 60 min; Insulin Lilly, Huminsulin, Lilly, Fegersheim, France
Intervention Type
Drug
Intervention Name(s)
Glucose
Intervention Description
Glucose: Dosage form : intravenous infusion, infusion period 60 minutes per dose level Dosage: at a rate to maintain blood glucose level at 100mg ; 20mg/100ml Glucose
Primary Outcome Measure Information:
Title
retinal blood flow after 1 hour of insulin clamp
Time Frame
2 x 2 minutes
Secondary Outcome Measure Information:
Title
Mean blood velocities in ophthalmic artery, posterior ciliary arteries and central retinal artery after 1 hour of insulin clamp
Time Frame
2 x 10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with IDDM: Age >= 19 years Best corrected visual acuity >= 0.8 Ametropia < 6 dpt Healthy control subjects: Age and sex matched to the subjects in the patients group Best corrected visual acuity >= 0.8 Ametropia < 6 dpt Exclusion Criteria: Any of the following will exclude a diabetic patient from the study: Presence of intraocular pathology other than diabetic retinopathy (for example: cataract, glaucoma, ocular hypertension) Hypertension (Systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg) Previous laser photocoagulation treatment Pregnancy (in women) Any of the following will exclude a healthy subject from the study: Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study Treatment in the previous 3 weeks with any drug Symptoms of a clinically relevant illness in the 3 weeks before the first study day History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs Blood donation during the previous 3 weeks Pregnancy (in women)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans-Georg Eichler, MD
Organizational Affiliation
Department of Clinical Pharmacology, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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The Relationship Between Stage of Diabetic Retinopathy and Retinal Blood Flow in Patients With IDDM During Euglycemic Clamp

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