Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT01097551
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01097551
Study Brief:
Protocol Section:
NCT01097551