Description of Insulin Resistance in Patients With Chroni... | NCT02013739

Studies
Description of Insulin Resistance in Patients With Chronic Heart Failure

NCT02013739

Sponsor

Hasselt University

Status

Completed

Last Update Posted

Dec 17, 2013Estimated

Enrollment

80Actual

Phase

Not provided

Conditions

Chronic Heart Failure

Interventions

Not provided

Countries

Belgium

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

Dec 2013

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 2012Actual

Completion Date

Dec 2013Actual

First Submitted Date

Dec 8, 2013

First Submission Date that Met QC Criteria

Dec 11, 2013

First Posted Date

Dec 17, 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

Dec 11, 2013

Last Update Posted Date

Dec 17, 2013Estimated

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 describe insulin resistance in a general chronic heart failure population, in combination with muscle strength, body composition and cardiac function.

It is assumed that insulin resistance is increased in CHF patient, and that this is related to decreased muscle strength and decreased lean tissue mass.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with chronic heart failure		other
Healthy volontiers		other

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glucose tolerance	glucose and insulin concentration measurements in blood during oral glucose tolerance test	day1

Secondary Outcomes

Measure	Description	Time Frame
HbA1c, blood lipids, BNP		day 1
Muscle strength: maximal strength tested on a isokinetic dynamometer		Day 1
Body composition: dual energy x-ray absorptiometry

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of chronic heart failure for at least 6 months,
clinically stable (not hospitalized) for more than 3 months prior to the onset of the study,

Exclusion Criteria:

glucose lowering medical therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with chronic heart failure

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bert Op 't Eijnde, prof. dr.	Hasselt University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hasselt University		Hasselt	Limburg	3500	Belgium