Endothelial Dysfunction and Diabetes

Overview

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.

Full Title of Study: “Assessment of Endothelial Dysfunction in Retinal and Peripheral Retinal Vessels in Diabetes”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2011

Detailed Description

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.

Interventions

  • Drug: Trinitrin
    • Trinitrin: 2 sublingual pulverisations of 0.3 mg/dose
  • Drug: Neosynephrine 10% collyrium
    • Neosynephrine 10% collyrium: 2 drops
  • Drug: Iontophoresis with acetylcholine delivery
    • Iontophoresis with acetylcholine delivery
  • Device: Dynamic Vessel Analyzer
    • Dynamic Vessel Analyzer

Arms, Groups and Cohorts

  • 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
  • Healthy subjects
    • Sex and age-matched control healthy subjects

Clinical Trial Outcome Measures

Primary Measures

  • Evaluation of the presence of a retinal endothelial dysfunction in patients with type 1 diabetes mellitus with Dynamic vessel analyser(assessment study visit)
    • Time Frame: up to 4 months

Secondary Measures

  • Presence of a peripheral endothelial dysfunction
    • Time Frame: up to 4 months
  • Correlation between retinal and peripheral endothelial dysfunction (assessment study visit)
    • Time Frame: up to 4 months
  • Serum concentration of: CRP, ICAM-1, VCAM-1, VEGF, angiopoietin 2 and endostatin.
    • Time Frame: up to 4 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Amélie LECLEIRE-COLLET, MD, Principal Investigator, Assistance Publique – Hôpitaux de Paris
    • Pascale MASSIN, MD, PhD, Principal Investigator, Assistance Publique – Hôpitaux de Paris

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