Metabolic Changes in Patients With Chronic Cardiopulmonary Disease

Heart Failure Clinical Trial

Official title:

Metabolic and Histological Changes in Skeletal Muscle and Fat Tissue in Patients With Chronic Cardiopulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02550808
• Other study ID #: ML-MTB-001
• Status: Recruiting
• Phase: N/A
• First received: September 3, 2015
• Last updated: September 15, 2015
• Start date: March 2012
• Est. completion date: December 2017

Study information

• Verified date: September 2015
• Source: General and Teaching Hospital Celje
• Contact: Mitja Lainscak
• Email: mitja.lainscak[@]guest.arnes.si
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Observational

Clinical Trial Summary

This study aims to evaluate prevalence of sarcopenia and cachexia in patients with chronic cardiopulmonary disease. The investigators will also investigate metabolic disorders like glucose metabolism, presence of metabolic syndrome, body composition and histological changes in skeletal muscle and body fat. Finally, patients will be followed for clinical endpoints.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of chronic disease (Heart failure, COPD, malignancy, CKD) or no diagnosis (controls)

Exclusion Criteria:

• refuse to participate

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Chronic Obstructive Pulmonary Disease
• Heart Failure
• Kidney Diseases
• Lung Diseases, Obstructive
• Malignancy
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Heart Disease
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Slovenia	General Hospital Celje	Celje

Sponsors (4)

Lead Sponsor	Collaborator
General and Teaching Hospital Celje	General Hospital Murska Sobota, Murska Sobota, Slovenia, Maastricht University, University of Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance (HOMA-IR)	HOMA-IR as calculated by formula using insulin and blood glucose	Baseline	No
Secondary	Muscle strength (Handgrip test)	Handgrip test	Baseline	No
Secondary	Change in exercise capacity (6 minute walk test)	Determined by incremental exercise test, 6 minute walk test	baseline and after 5 weeks	No
Secondary	Neurohormonal activation (NT-proBNP concentration)	NT-proBNP concentration	Baseline	No
Secondary	Change in apoptosis in skeletal muscle (number of apoptotic cells per square mm)	histological evaluation: number of apoptotic cells per square mm	Baseline and after 5 weeks	No
Secondary	Change in insulin resistance (HOMA-IR)	HOMA-IR as calculated by formula using insulin and blood glucose	Baseline and after 5 weeks	No