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CompletedNCT01097551DENDIUpdated Jul 3, 2012

Endothelial Dysfunction and Diabetes

An observational study in Type 1 Diabetes Mellitus, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-03.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
38
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Type 1 Diabetes Mellitus

Keywords

  • Type 1 diabetes mellitus
  • Diabetic retinopathy
  • Pathogenesis
  • Dynamic Vessel Analyser
  • Endothelial dysfunction
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 38 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
38 participants (actual)

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

    Drug: Trinitrin · Drug: Neosynephrine 10% collyrium · Drug: Iontophoresis with acetylcholine delivery · Device: Dynamic Vessel Analyzer

  • Healthy subjects

    Sex and age-matched control healthy subjects

    Drug: Trinitrin · Drug: Neosynephrine 10% collyrium · Drug: Iontophoresis with acetylcholine delivery · Device: Dynamic Vessel Analyzer

Interventions

  • DrugTrinitrin

    Trinitrin: 2 sublingual pulverisations of 0.3 mg/dose

  • DrugNeosynephrine 10% collyrium

    Neosynephrine 10% collyrium: 2 drops

  • DrugIontophoresis with acetylcholine delivery

    Iontophoresis with acetylcholine delivery

  • DeviceDynamic Vessel Analyzer

    Dynamic Vessel Analyzer

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Presence of a peripheral endothelial dysfunction

    Time frame: up to 4 months

  2. Correlation between retinal and peripheral endothelial dysfunction (assessment study visit)

    Time frame: up to 4 months

  3. Serum concentration of: CRP, ICAM-1, VCAM-1, VEGF, angiopoietin 2 and endostatin.

    Time frame: up to 4 months

07

Study locations

1 site
  • Hôpital LARIBOISIERE Service d'Ophtalmologie
    Paris, 75010, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01097551
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Apr 1, 2010
Start date
Jan 2011
Primary completion
Jul 2011
Completion
Jul 2011
Last update
Jul 3, 2012

Study contacts

Amélie LECLEIRE-COLLET, MD
principal investigator · Assistance Publique - Hôpitaux de Paris
Pascale MASSIN, MD, PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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