Effect of Aldosterone Blockade on Arterial Compliance (RAAS LAEI SAEI)

Wolfson Medical Center (WMC)

Status and phase: Completed; Phase 4

Conditions: Arterial Elasticity; Arterial Stiffness

Treatments: Drug: Spironolactone

Study type: Interventional

Funder types: Other

Identifiers

NCT01089309

WolfsonMC-2004-388

Details and patient eligibility

About

The present study investigated the long-term (12 months) effect of spironolactone treatment on glucose homeostasis, metabolic parameters and vascular properties.

Enrollment: 51 patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. patients with type 2 diabetes mellitus

Exclusion criteria

1. history of unstable angina, myocardial infarction (MI), cerebrovascular accident (CVA)
2. major surgery within the six months preceding entrance to the study
3. unbalanced endocrine disease
4. any disease that might affect absorption of medications
5. plasma creatinine >2.5 mg/dl
6. elevation of liver enzymes to more that twice the upper normal limit
7. plasma potassium levels >5.5 mg/dl

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

51 participants in 1 patient group

Aldosteron blokade, Arterial stiffness, Glucose homeostasis

Experimental group

Treatment:

Drug: Spironolactone