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

NCT ID: NCT00814008

Last Updated: 2008-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-03-31

Study Completion Date

2003-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 1 Insulin Retina Regional Blood Flow

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Department of Clinical Pharmacology, Medical University of Vienna

Principal Investigators

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Hans-Georg Eichler, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Medical University of Vienna

Locations

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Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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OPHT-181298

Identifier Type: -

Identifier Source: org_study_id