Metabolic Changes in Patients With Chronic Cardiopulmonary Disease

NCT02550808 | Unknown

• 1 other identifier: ML-MTB-001
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Chronic Obstructive Pulmonary Disease; Malignancy; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Insulin resistance (HOMA-IR)

  HOMA-IR as calculated by formula using insulin and blood glucose

  Baseline

Secondary Outcomes (5)

• Muscle strength (Handgrip test)

  Baseline

• Change in exercise capacity (6 minute walk test)

  baseline and after 5 weeks

• Neurohormonal activation (NT-proBNP concentration)

  Baseline

• Change in apoptosis in skeletal muscle (number of apoptotic cells per square mm)

  Baseline and after 5 weeks

• Change in insulin resistance (HOMA-IR)

  Baseline and after 5 weeks

Study Arms (5)

Heart failure

Chronic obstructive pulmonary disease

Chronic kidney disease

Malignancy

Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic disease (Heart failure, COPD, malignancy, CKD) and healthy controls

You may qualify if:

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

You may not qualify if:

• refuse to participate

Sponsors & Collaborators

• General and Teaching Hospital Celje: lead
• University of Ljubljana: collaborator
• General Hospital Murska Sobota: collaborator
• Maastricht University: collaborator

Study Sites (1)

General Hospital Celje

Celje, SI-3000, Slovenia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum; plasma; Skeletal muscle; fat tissue; urine; full blood

MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive; Neoplasms; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Mitja Lainscak

CONTACT

mitja.lainscak@guest.arnes.si

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 16, 2015
• Study Start: March 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2017
• Last Updated: September 16, 2015

Record last verified: 2015-09

Locations

SL (1)