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Energy Metabolism for the Patients With Pulmonary Mycobacterium Avium Complex

Sponsor
National Hospital Organization Minami Kyoto Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03550820
Collaborator
(none)
105
Enrollment
1
Location
43.9
Actual Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We aim to examine energy metabolism in patients with pulmonary MAC and clarify the causes of emaciation. We will also investigate the following: the relation between energy metabolism and degree of pulmonary MAC progression; relations among hospitalization, mortality rate, and time-course of changes in energy metabolism; and factors that affect energy metabolism.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients with pulmonary MAC with a lower BMI than healthy individuals also have a significantly poorer prognosis than those of normal weight. Emaciation in such patients is thought to be caused by destruction of lung structure from disease progression and an increased resting metabolic rate caused by the increased load from breathing; however, causes of emaciation and details of energy metabolism in these patients have not been studied.

    Elucidating details of energy metabolism and causes of emaciation in patients with pulmonary MAC could provide the basis for improvement in nutritional status and activities of daily living through early nutrition therapy and rehabilitation. We propose to clarify the following:

    Energy metabolism in patients with pulmonary MAC, including resting metabolic rate, calorie intake and consumption, and hormonal secretions.

    Relation between energy metabolism and degree of pulmonary MAC progression.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    105 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Energy Metabolism for the Patients With Pulmonary Mycobacterium Avium Complex
    Actual Study Start Date :
    May 1, 2018
    Actual Primary Completion Date :
    Dec 27, 2021
    Actual Study Completion Date :
    Dec 27, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Relation between energy balance and pulmonary MAC severity [Three years]

    Secondary Outcome Measures

    1. Relation between inflammation (CRP et.) and pulmonary MAC severity [Three years]

    2. Relation between bone mineral density and pulmonary MAC severity [Three years]

    3. Relation between hormone secretion and pulmonary MAC severity [Three years]

    4. Relation between pulmonary function and pulmonary MAC severity [Three years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subjects with pulmonary MAC.
    Exclusion Criteria:
    • Subjects with severe cardiovascular disease, diabetes, neurological disease, renal failure, endocrine disease and malignant neoplasm.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Hospital Organization Minami Kyoto Hospital Joyo Kyoto Japan 610-0113

    Sponsors and Collaborators

    • National Hospital Organization Minami Kyoto Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Hospital Organization Minami Kyoto Hospital
    ClinicalTrials.gov Identifier:
    NCT03550820
    Other Study ID Numbers:
    • 28-2
    First Posted:
    Jun 8, 2018
    Last Update Posted:
    Dec 28, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Hospital Organization Minami Kyoto Hospital
    pulmonary MAC
    energy metabolism
    Additional relevant MeSH terms:
    Mycobacterium avium-intracellulare Infection
    Emaciation

    Study Results

    No Results Posted as of Dec 28, 2021