Effect of Bosentan on Endothelial Function in Patients With Type 2 Diabetes

Karolinska Institutet56 enrolled

Overview

The purpose of the study is to investigate if oral treatment with bosentan improves endothelium-dependent vasodilatation in patients with type 2 diabetes and microangiopathy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

BosentanDRUG

62.5 mg bid for two weeks and 125 mg bid for two weeks

PlaceboDRUG

Matched placebo bid

Eligibility

Sex: ALLMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diabetes mellitus type 2 of \>2 years duration 2. Albuminuria Exclusion Criteria: 1. Age \>80 years 2. Myocardial infarction/unstable angina within three months prior to randomisation 3. Decompensated congestive heart failure or functional class 3 and 4. 4. Changes in dosage of any vasodilator drugs during the preceding six weeks 5. Women of fertile age. 6. Impaired hepatic function (2 times upper normal limit of aminotransferases ASAT and ALAT) 7. Ongoing treatment with glibenclamide, cyclosporin or warfarin 8. Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol 9. Participant in an ongoing study 10. Unwillingness to participate following oral and written information

Locations (1)

Karolinska Institutet, Karolinska University Hospital

Stockholm, Sweden

Outcomes

Primary Outcomes

Peripheral endothelial function

Time frame: 4 weeks

Secondary Outcomes

Inflammatory markers

Time frame: 4 weeks

Renal protein excretion

Time frame: 4 weeks

Myocardial perfusion

Time frame: 4 weeks

Data from ClinicalTrials.gov

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