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Metabolic Changes in Patients With Chronic Cardiopulmonary Disease

Sponsor
General and Teaching Hospital Celje (Other)
Overall Status
Unknown status
CT.gov ID
NCT02550808
Collaborator
University of Ljubljana (Other), General Hospital Murska Sobota (Other), Maastricht University (Other)
400
Enrollment
1
Location
69
Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Metabolic and Histological Changes in Skeletal Muscle and Fat Tissue in Patients With Chronic Cardiopulmonary Disease
    Study Start Date :
    Mar 1, 2012
    Anticipated Primary Completion Date :
    Jul 1, 2016
    Anticipated Study Completion Date :
    Dec 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Heart failure
    Chronic obstructive pulmonary disease
    Chronic kidney disease
    Malignancy
    Controls

    Outcome Measures

    Primary Outcome Measures

    1. Insulin resistance (HOMA-IR) [Baseline]

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

    Secondary Outcome Measures

    1. Muscle strength (Handgrip test) [Baseline]

      Handgrip test

    2. Change in exercise capacity (6 minute walk test) [baseline and after 5 weeks]

      Determined by incremental exercise test, 6 minute walk test

    3. Neurohormonal activation (NT-proBNP concentration) [Baseline]

      NT-proBNP concentration

    4. 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

    5. Change in insulin resistance (HOMA-IR) [Baseline and after 5 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • diagnosis of chronic disease (Heart failure, COPD, malignancy, CKD) or no diagnosis (controls)
    Exclusion Criteria:
    • refuse to participate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 General Hospital Celje Celje Slovenia SI-3000

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mitja Lainscak, Professor of Internal Medicine, General and Teaching Hospital Celje
    ClinicalTrials.gov Identifier:
    NCT02550808
    Other Study ID Numbers:
    • ML-MTB-001
    First Posted:
    Sep 16, 2015
    Last Update Posted:
    Sep 16, 2015
    Last Verified:
    Sep 1, 2015
    Additional relevant MeSH terms:
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive
    Kidney Diseases
    Renal Insufficiency, Chronic
    Pulmonary Heart Disease

    Study Results

    No Results Posted as of Sep 16, 2015