ET-blockade and Exercise-induced Vascular Adaptations in T2DM

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Effect of a Dual ET(Endothelin)-Blocker on Exercise Induced Vascular Adaptations in Type 2 Diabetes Mellitus (T2DM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01779609
• Other study ID #: ET-EX-TRAINING
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2013
• Last updated: May 4, 2016
• Start date: April 2010
• Est. completion date: December 2013

Study information

• Verified date: May 2016
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Bosentan

• Placebo

Behavioral:
• Exercise
Supervised exercise training program of 8 weeks, for 3x/week

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Actelion

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow mediated dilation		8 weeks	No
Secondary	Conduit Artery Dilator Capacity		8 weeks	No
Secondary	Intima-Media Thickness		8 weeks	No
Secondary	Maximal Oxygen Uptake		8 weeks	No