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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00814008
First received: December 22, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 1
Insulin
Retina
Regional Blood Flow
 Drug: Insulin
Drug: Glucose
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Relationship Between Stage of Diabetic Retinopathy and Retinal Blood Flow in Patients With IDDM During Euglycemic Clamp

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • retinal blood flow after 1 hour of insulin clamp [ Time Frame: 2 x 2 minutes ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 64
Study Start Date: March 1999
Study Completion Date: December 2003
Primary Completion Date: April 2000 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Insulin
    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
    Drug: Glucose

    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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814008

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Hans-Georg Eichler, MD Department of Clinical Pharmacology, Medical University of Vienna
  More Information

No publications provided

Responsible Party: Hans-Georg Eichler, MD, Department of Clinical Pharmacology, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00814008     History of Changes
Other Study ID Numbers: OPHT-181298
Study First Received: December 22, 2008
Last Updated: December 22, 2008
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetic Retinopathy
Retinal Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune 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 19, 2013