Description of Insulin Resistance in Patients With Chronic Heart Failure

Chronic Heart Failure Clinical Trial

Official title:

Description of Insulin Resistance and Explanatory Variables in Patients With Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02013739
• Other study ID #: 11.78/cardio11.13
• Status: Completed
• Phase: N/A
• First received: December 8, 2013
• Last updated: December 11, 2013
• Start date: May 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure
• Insulin Resistance

Locations

Country	Name	City	State
Belgium	Hasselt University	Hasselt	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose tolerance	glucose and insulin concentration measurements in blood during oral glucose tolerance test	day1	No
Secondary	HbA1c, blood lipids, BNP		day 1	No
Secondary	Muscle strength: maximal strength tested on a isokinetic dynamometer		Day 1	No
Secondary	Body composition: dual energy x-ray absorptiometry		Day 1	No
Secondary	cardiac function: echocardiography, retrospective from hospital files		retrospective	No
Secondary	Health-related quality of life: MLHFQ and Eq5d		Day 1	No