Endothelial Dysfunction and Diabetes
DENDI
Assessment of Endothelial Dysfunction in Retinal and Peripheral Retinal Vessels in Diabetes
2 other identifiers
observational
38
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2010
CompletedFirst Posted
Study publicly available on registry
April 1, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedJuly 3, 2012
July 1, 2012
6 months
March 31, 2010
July 2, 2012
Conditions
Keywords
Outcome Measures
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)
up to 4 months
Secondary Outcomes (3)
Presence of a peripheral endothelial dysfunction
up to 4 months
Correlation between retinal and peripheral endothelial dysfunction (assessment study visit)
up to 4 months
Serum concentration of: CRP, ICAM-1, VCAM-1, VEGF, angiopoietin 2 and endostatin.
up to 4 months
Study Arms (2)
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
Interventions
Trinitrin: 2 sublingual pulverisations of 0.3 mg/dose
Neosynephrine 10% collyrium: 2 drops
Iontophoresis with acetylcholine delivery
Eligibility Criteria
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
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital LARIBOISIERE Service d'Ophtalmologie
Paris, 75010, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amélie LECLEIRE-COLLET, MD
Assistance Publique - Hôpitaux de Paris
- PRINCIPAL INVESTIGATOR
Pascale MASSIN, MD, PhD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2010
First Posted
April 1, 2010
Study Start
January 1, 2011
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
July 3, 2012
Record last verified: 2012-07