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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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ClinicalTrials.gov Identifier: NCT00814008
Recruitment Status : Completed
First Posted : December 23, 2008
Last Update Posted : December 23, 2008
Sponsor:
Information provided by:
Medical University of Vienna

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 1999
Actual Primary Completion Date : April 2000
Actual Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources


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



Primary Outcome Measures :
  1. retinal blood flow after 1 hour of insulin clamp [ Time Frame: 2 x 2 minutes ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 23, 2008    Key Record Dates
Last Update Posted: December 23, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Retinopathy
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs