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NCT03550820 Clinical Trial

Energy Metabolism for the Patients With Pulmonary Mycobacterium Avium Complex

Energy Metabolism Clinical Trial

Official title:
Energy Metabolism for the Patients With Pulmonary Mycobacterium Avium Complex

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03550820
Other study ID # 28-2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2018
Est. completion date December 27, 2021

Study information
Verified date December 2021
Source National Hospital Organization Minami Kyoto Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 105
Est. completion date December 27, 2021
Est. primary completion date December 27, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - Subjects with pulmonary MAC. Exclusion Criteria: - Subjects with severe cardiovascular disease, diabetes, neurological disease, renal failure, endocrine disease and malignant neoplasm.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan National Hospital Organization Minami Kyoto Hospital Joyo Kyoto

Sponsors (1)
Lead Sponsor Collaborator
National Hospital Organization Minami Kyoto Hospital

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Relation between energy balance and pulmonary MAC severity Three years
Secondary Relation between inflammation (CRP et.) and pulmonary MAC severity Three years
Secondary Relation between bone mineral density and pulmonary MAC severity Three years
Secondary Relation between hormone secretion and pulmonary MAC severity Three years
Secondary Relation between pulmonary function and pulmonary MAC severity Three years
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