NCT01779596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started May 2011

Typical duration for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 4, 2016

Status Verified

May 1, 2016

Enrollment Period

2.6 years

First QC Date

January 28, 2013

Last Update Submit

May 3, 2016

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetesendothelial functionexerciseblood flowbosentan

Outcome Measures

Primary Outcomes (1)

  • exercise induced blood flow

    2 hours

Secondary Outcomes (1)

  • exercise induced Flow Mediated Dilation

    2 hours

Study Arms (2)

Bosentan

EXPERIMENTAL

Single dose of Bosentan (125 mg)

Drug: Bosentan

Placebo

PLACEBO COMPARATOR

Single dose of placebo (125 mg)

Drug: Placebo

Interventions

BosentanDRUG
Also known as: Tracleer, actelion pharmaceuticals, 125 mg oral dose
Bosentan
PlaceboDRUG
Also known as: actelion pharmaceuticals, 125 mg oral dose
Placebo

Eligibility Criteria

Age40 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6525 EX, Netherlands

Location

Related Publications (1)

  • Schreuder TH, van Lotringen JH, Hopman MT, Thijssen DH. Impact of endothelin blockade on acute exercise-induced changes in blood flow and endothelial function in type 2 diabetes mellitus. Exp Physiol. 2014 Sep;99(9):1253-64. doi: 10.1113/expphysiol.2013.077297. Epub 2014 May 16.

    PMID: 24928953DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusMotor Activity

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2013

First Posted

January 30, 2013

Study Start

May 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 4, 2016

Record last verified: 2016-05

Locations

NL(1)