Metabolic Changes in Patients With Chronic Cardiopulmonary Disease

• Conditions: Heart Failure; Chronic Kidney Disease; Chronic Obstructive Pulmonary Disease; Malignancy

• Registration Number: NCT02550808
• Lead Sponsor: General and Teaching Hospital Celje

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Status Verified: 2015-09
• Study First Submitted: 2015-09-03
• Study First Submitted QC: 2015-09-15
• Last Update Submitted: 2015-09-15
• Study First Posted: 2015-09-16
• Last Update Posted: 2015-09-16
• Primary Completion: 2016-07
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

• refuse to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insulin resistance (HOMA-IR)	Baseline	HOMA-IR as calculated by formula using insulin and blood glucose

Secondary Outcome Measures

Name	Time	Method
Muscle strength (Handgrip test)	Baseline	Handgrip test
Change in apoptosis in skeletal muscle (number of apoptotic cells per square mm)	Baseline and after 5 weeks	histological evaluation: number of apoptotic cells per square mm
Change in exercise capacity (6 minute walk test)	baseline and after 5 weeks	Determined by incremental exercise test, 6 minute walk test
Neurohormonal activation (NT-proBNP concentration)	Baseline	NT-proBNP concentration
Change in insulin resistance (HOMA-IR)	Baseline and after 5 weeks	HOMA-IR as calculated by formula using insulin and blood glucose

Trial Locations

Locations (1)

General Hospital Celje; 🇸🇮 Celje, Slovenia