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Energy Metabolism for the Patients With Pulmonary Mycobacterium Avium Complex

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ClinicalTrials.gov Identifier: NCT03550820
Recruitment Status : Active, not recruiting
First Posted : June 8, 2018
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
National Hospital Organization Minami Kyoto Hospital

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
Pulmonary MAC Energy Metabolism Emaciation

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.

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Relation between energy balance and pulmonary MAC severity [ Time Frame: Three years ]

Secondary Outcome Measures :
  1. Relation between inflammation (CRP et.) and pulmonary MAC severity [ Time Frame: Three years ]
  2. Relation between bone mineral density and pulmonary MAC severity [ Time Frame: Three years ]
  3. Relation between hormone secretion and pulmonary MAC severity [ Time Frame: Three years ]
  4. Relation between pulmonary function and pulmonary MAC severity [ Time Frame: Three years ]

Biospecimen Retention:   Samples Without DNA
Blood samples (serum, plasma)


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Petients with pulmonary MAC
Criteria

Inclusion Criteria:

  • Subjects with pulmonary MAC.

Exclusion Criteria:

  • Subjects with severe cardiovascular disease, diabetes, neurological disease, renal failure, endocrine disease and malignant neoplasm.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550820


Locations
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Japan
National Hospital Organization Minami Kyoto Hospital
Joyo, Kyoto, Japan, 610-0113
Sponsors and Collaborators
National Hospital Organization Minami Kyoto Hospital

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Responsible Party: National Hospital Organization Minami Kyoto Hospital
ClinicalTrials.gov Identifier: NCT03550820    
Other Study ID Numbers: 28-2
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019

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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:
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Mycobacterium avium-intracellulare Infection
Emaciation
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Nontuberculous
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms