Status:
COMPLETED
Cardiovascular Effects of Chronic Sildenafil in Men With Type 2 Diabetes
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Diabetes Mellitus, Type 2
Endothelial Dysfunction
Eligibility:
MALE
35-75 years
Phase:
PHASE4
Brief Summary
Type 2 Diabetes Mellitus (T2DM) represents a model of endothelial dysfunction, where chronic nitric oxide deprivation, hyperglycaemia and hyperinsulinemia and fibrogenic mediators lead to cardiovascul...
Detailed Description
Type 2 Diabetes Mellitus (T2DM) represents a model of endothelial dysfunction at central and peripheral levels, where chronic nitric oxide deprivation, due to hyperglycaemia, leads to a loss of vascul...
Eligibility Criteria
Inclusion
- Patients with type 2 diabetes mellitus
- Patients age 35-75
- Metabolic control of diabetes by diet or oral treatment (unmodified in the last 3 months)
- Blood pressure \<160/100 mmHg, including subjects with controlled hypertension, treated with ACE-inhibitors/sartans, unmodified in the last 3 months
Exclusion
- Participation in another study with an investigational drug or device
- HbA1c \>12%
- Alterations during ECG stress examination
- Current use of nitrate agents
- Proliferative retinopathy
- Patients with history of cardiovascular and malignant disease
- Psychosocial disturbance
- Alcohol or drug dependence
- Allergy or hypersensitivity to sildenafil or other Phosphodiesterase inhibitors.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00692237
Start Date
January 1 2008
End Date
December 1 2009
Last Update
May 8 2013
Active Locations (1)
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1
Dipartimento di Fisiopatologia Medica - Policlinico Umberto I
Rome, Italy, 00161