ET-blockade and Exercise Induced Blood Flow in T2DM | NCT01779596

Studies
ET-blockade and Exercise Induced Blood Flow in T2DM

NCT01779596

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

May 4, 2016Estimated

Enrollment

22Actual

Phase

Phase 4

Conditions

Type 2 Diabetes Mellitus

Interventions

Bosentan
Placebo

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jan 28, 2013

First Submission Date that Met QC Criteria

Jan 28, 2013

First Posted Date

Jan 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2016

Last Update Posted Date

May 4, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bosentan	Experimental	Single dose of Bosentan (125 mg)	Drug: Bosentan
Placebo	Placebo Comparator	Single dose of placebo (125 mg)	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bosentan	Drug		Bosentan	Tracleer actelion pharmaceuticals 125 mg oral dose

Measure	Description	Time Frame
exercise induced blood flow		2 hours

Measure	Description	Time Frame
exercise induced Flow Mediated Dilation		2 hours

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radboud University Nijmegen Medical Centre		Nijmegen	Gelderland	6525 EX	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24928953	Derived	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.

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus
D009043	Motor Activity

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals