Diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Interventions
Trade Name: Lisinopril
Product Name: lisinopril
Product Code: 26330
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Academic Medical Centre
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Caucasian males Diagnosis of type 1 diabetes Urinary alb/creat ratio =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Hypertension (RR syst > 140 mmHg, RR diast. > 90 mmHg) Previous use of RAS inhibitors Smoking Primary dyslipidemia's Use of statins during the six weeks before visit 1 Use of antioxidants in the two weeks prior to visit 1 Angioedema in medical history Hypersensitivity to ACE inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of ACE inhibition on the microvascular endothelial glycocalyx in patients with type 1 diabetes;Secondary Objective: (a)To determine whether the (hypothesized) effect of ACE inhibition on the endothelial glycocalyx can be explained by (1) a reduction in oxidative stress (2) a reduction in inflammation. (b)To determine whether the improvement in endothelial glycocalyx thickness correlates with a reduction in micro albuminuria as well as an improvement in glomerular charge selectivity. (c)To determine whether the expected improvement of microvascular glycocalyx thickness by treatment with ACE inhibition has an effect on markers of coagulation and fibrinolysis;Primary end point(s): Change in microvascular glycocalyxthickness | — |
Countries
Netherlands
Outcome results
None listed