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Endothelial Dysfunction and Diabetes

NCT ID: NCT01097551

Last Updated: 2012-07-03

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

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-07-31

Brief Summary

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The aim of the study is to progress in the understanding of the early retinal vascular and neural abnormalities in patients with diabetes, using a new device, the Dynamic Vessel Analyzer. The Dynamic Vessel Analyzer allows to measure the diameter of the retinal vessels and to assess how it varies in presence of various stimuli. Then, we will be able to assess if a vascular and/or a neural dysfunction is present early in patient with diabetes.

Detailed Description

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Twenty patients with type 1 diabetes without diabetic retinopathy and without arterial hypertension will be compared with 20 sex and aged-matched healthy control subjects. To assess the presence of retinal endothelial dysfunction, the variations of the diameters of the retinal vessels will be assessed using the Dynamic Vessel Analyzer, before and after flicker light stimulation, sublingual nitroglycerin, neosynephrine eyedrops, and isometric contraction. To assess the presence of peripheral endothelial dysfunction, the microcirculation of the forearm skin will be studied using iontophoresis with acetylcholine delivery, and heat delivery, both coupled with blood flow measurement using laser Doppler. An intravital capillaroscopy of the phalanx skin will be performed. The serum levels of CRP, ICAM-1, VCAM-1, VEGF, angiopoietin 2 and endostatin will also be measured.

Conditions

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Type 1 Diabetes Mellitus

Keywords

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Type 1 diabetes mellitus Diabetic retinopathy Pathogenesis Dynamic Vessel Analyser Endothelial dysfunction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with type 1 diabetes

Diabetes duration \>= 5 years, age \>= 18 and \<= 60 years old, patients with no visible diabetic retinopathy, and no arterial hypertension

Trinitrin

Intervention Type DRUG

Trinitrin: 2 sublingual pulverisations of 0.3 mg/dose

Neosynephrine 10% collyrium

Intervention Type DRUG

Neosynephrine 10% collyrium: 2 drops

Iontophoresis with acetylcholine delivery

Intervention Type DRUG

Iontophoresis with acetylcholine delivery

Dynamic Vessel Analyzer

Intervention Type DEVICE

Dynamic Vessel Analyzer

Healthy subjects

Sex and age-matched control healthy subjects

Trinitrin

Intervention Type DRUG

Trinitrin: 2 sublingual pulverisations of 0.3 mg/dose

Neosynephrine 10% collyrium

Intervention Type DRUG

Neosynephrine 10% collyrium: 2 drops

Iontophoresis with acetylcholine delivery

Intervention Type DRUG

Iontophoresis with acetylcholine delivery

Dynamic Vessel Analyzer

Intervention Type DEVICE

Dynamic Vessel Analyzer

Interventions

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Trinitrin

Trinitrin: 2 sublingual pulverisations of 0.3 mg/dose

Intervention Type DRUG

Neosynephrine 10% collyrium

Neosynephrine 10% collyrium: 2 drops

Intervention Type DRUG

Iontophoresis with acetylcholine delivery

Iontophoresis with acetylcholine delivery

Intervention Type DRUG

Dynamic Vessel Analyzer

Dynamic Vessel Analyzer

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* For diabetic patients :

* age between 20 and 60
* type 1 diabetes mellitus
* diabetes duration of more than 5 years
* no diabetic retinopathy on fundus examination or fundus photographs
* no systemic hypertension (defined as systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg)
* For control subjects :

* sex and age matching with the diabetic patients
* no diabetes, no familial or personal history of elevated blood sugar
* Non-diabetic subjects, criteria defined by a fasting glucose \<1.10 g / l and an HbA1c \<6.5% (according to Lariboisière biochemistry laboratory HbA1c)
* no systemic hypertension (defined as systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg)
* Subject with a normal ophthalmologic examination
* For both diabetic patients and control subjects :

* Subject that has signed informed consent
* Subject affiliated to a social security
* Subject available for a period of 4 months

Exclusion Criteria

* For both diabetic patients and control subjects :

* presence of cataract or history of cataract surgery
* intraocular pressure of more than 21 mmHg
* treatment with vasoactive drugs
* tobacco consumption of more than 20 cigarettes a day
* Contraindications to trinitrin administration: hypersensitivity to trinitrin, treatment by sildenafil, heart disease, severe arterial hypotension, bradycardia, intracranial hypertension
* Clinical Raynaud syndrome
* Pregnant or breast-feeding subject
* Subject whose age is \<18 and\> 60 years on the day of inclusion
* Subject with cardiac disease, severe hypotension (BP \<80/50 mmHg), a resting heart rate below 50 beats / minute
* Subject intracranial hypertension
* Subject with a current consumption of drugs or drugs that may impact vasomotion (antiglaucoma eye drops, vasodilators, antihypertensive drugs). Vasoactive drug use will be prohibited within 24 hours preceding the study.
* Subject has not signed an informed consent
* Subject not affiliated to a social security
* Subject not available for a period of 4 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amélie LECLEIRE-COLLET, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Pascale MASSIN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hôpital LARIBOISIERE Service d'Ophtalmologie

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2009-A0109552

Identifier Type: OTHER

Identifier Source: secondary_id

P080608

Identifier Type: -

Identifier Source: org_study_id