Endothelial Dysfunction and Diabetes

Type 1 Diabetes Mellitus Clinical Trial

— DENDI  

Official title:

Assessment of Endothelial Dysfunction in Retinal and Peripheral Retinal Vessels in Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097551
• Other study ID #: P080608
• Secondary ID: 2009-A0109552
• Status: Completed
• Phase: N/A
• First received: March 31, 2010
• Last updated: July 2, 2012
• Start date: January 2011
• Est. completion date: July 2011

Study information

• Verified date: July 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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

Device:
• Dynamic Vessel Analyzer
Dynamic Vessel Analyzer

Locations

Country	Name	City	State
France	Hôpital LARIBOISIERE Service d'Ophtalmologie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the presence of a retinal endothelial dysfunction in patients with type 1 diabetes mellitus with Dynamic vessel analyser(assessment study visit)		up to 4 months	No
Secondary	Presence of a peripheral endothelial dysfunction		up to 4 months	No
Secondary	Correlation between retinal and peripheral endothelial dysfunction (assessment study visit)		up to 4 months	No
Secondary	Serum concentration of: CRP, ICAM-1, VCAM-1, VEGF, angiopoietin 2 and endostatin.		up to 4 months	No