In patients with diabetes mellitus type II with and without microalbuminuria.
Conditions
Interventions
Patients with DM type II and healthy volunteers will visit the hospital on 4 occasions: screening-inclusion visit, end of study period I, end of washout visit and end of study period II. At the end of
Sponsors
AlfaWasserman, Italy
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria are: 1. Male; 2. Age between 18 and 65 years.
Exclusion criteria
Exclusion criteria: Exclusion criteria are: 1. Smoking; 2. Immunosuppressive drugs; 3. Serious previous illnesses; 4. Coagulation disorders; 5. Primary dyslipidemias; 6. BMI > 30 kg/m2; 7. Hypertension (systolic >140 mm Hg or diastolic >90 mm Hg).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoint: The difference in systemic glycocalyx volume after sulodexide and after placebo treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints (if applicable) The difference in systemic glycocalyx volume after sulodexide and after placebo treatment in local sublingual glycocalyx volume, vascular permeability and endothelial function in all patients. The percentage change from baseline to end of the study in microalbuminuria in patients with DM type II who have microalbuminuria. | — |
Contacts
Public ContactL.N. Broekhuizen
Academic Medical Center (AMC), Department of Vascular medicine F4-142 P.O. Box 22660
Outcome results
None listed