ET-blockade and Exercise Induced Blood Flow in T2DM

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: Bosentan

• Registration Number: NCT01779596
• Lead Sponsor: Radboud University Medical Center

Brief Summary

The purpose of this study is to establish the effect of ET blockade on the acute exercise induced blood flow and endothelial function in subjects with T2DM. We hypothesize that combining ET - blockade with exercise training leads to an acute increase of exercise induced blood flow when compared with exercise alone. We expect that this will lead to an optimization of vascular training effect in T2DM.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2013-01-28
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-30
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-03
• Last Update Posted: 2016-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 22

Inclusion Criteria

• Type 2 Diabetes Mellitus (>2 years since diagnosis) OR controls

Exclusion Criteria

• <40 years of age
• >65 years of age
• smoking
• cardiovascular disease
• diabetes related manifest vascular complications
• Type 1 Diabetes Mellitus
• use of Glibenclamide
• use of HIV drugs
• use of calcineurin inhibitors
• use of drugs that interfere with CYP3A4 and CYP2C19

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Single dose of placebo (125 mg)
Bosentan	Bosentan	Single dose of Bosentan (125 mg)

Primary Outcome Measures

Name	Time	Method
exercise induced blood flow	2 hours

Secondary Outcome Measures

Name	Time	Method
exercise induced Flow Mediated Dilation	2 hours

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Gelderland, Netherlands