ET-blockade and Exercise-induced Vascular Adaptations in T2DM

Phase 4

Completed

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

• Registration Number: NCT01779609
• Lead Sponsor: Radboud University Medical Center

Brief Summary

The purpose of this study is to establish the effect of ET blockade on vascular adaptations during an 8-week exercise program 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: 2010-04
• 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: 2016-05-04
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bosentan + Exercise	Exercise	2x/day 62.5 mg Bosentan for 4 weeks alongside 3x/week supervised exercise 2x/day 125 mg Bosentan for 4 weeks alongside 3x/week supervised exercise
Exercise	Exercise	3x/week supervised exercise for 8 weeks
Placebo + Exercise	Exercise	2x/day 62.5 mg Placebo for 4 weeks alongside 3x/week supervised exercise 2x/day 125 mg Placebo for 4 weeks alongside 3x/week supervised exercise
Placebo + Exercise	Placebo	2x/day 62.5 mg Placebo for 4 weeks alongside 3x/week supervised exercise 2x/day 125 mg Placebo for 4 weeks alongside 3x/week supervised exercise
Bosentan + Exercise	Bosentan	2x/day 62.5 mg Bosentan for 4 weeks alongside 3x/week supervised exercise 2x/day 125 mg Bosentan for 4 weeks alongside 3x/week supervised exercise

Primary Outcome Measures

Name	Time	Method
Flow mediated dilation	8 weeks

Secondary Outcome Measures

Name	Time	Method
Maximal Oxygen Uptake	8 weeks
Intima-Media Thickness	8 weeks
Conduit Artery Dilator Capacity	8 weeks

Trial Locations

Locations (1)

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