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CompletedNCT03550820Updated Dec 28, 2021

Energy Metabolism for the Patients With Pulmonary Mycobacterium Avium Complex

An observational study in Pulmonary MAC, Energy Metabolism and Emaciation, sponsored by National Hospital Organization Minami Kyoto Hospital. Completed at 1 site in Japan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-12-28.

Sponsored by National Hospital Organization Minami Kyoto Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
105
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pulmonary MAC
  • Energy Metabolism
  • Emaciation

Keywords

  • pulmonary MAC
  • energy metabolism
03

In context

Mycobacterium avium-intracellulare Infection

72 studies on the registry are indexed under Mycobacterium avium-intracellulare Infection; 8 are open to participants now.

This study's enrollment of 105 is close to the median of 100 across 12 observational studies indexed under Mycobacterium avium-intracellulare Infection.

Browse Mycobacterium avium-intracellulare Infection studies →

Lead sponsor

National Hospital Organization Minami Kyoto Hospital is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Petients with pulmonary MAC

Inclusion criteria

  • Subjects with pulmonary MAC.

Exclusion criteria

Exclusion Criteria:

  • Subjects with severe cardiovascular disease, diabetes, neurological disease, renal failure, endocrine disease and malignant neoplasm.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
105 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Relation between energy balance and pulmonary MAC severity

    Time frame: Three years

Secondary outcomes

  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

07

Study locations

1 site
  • National Hospital Organization Minami Kyoto Hospital
    Joyo, Kyoto 610-0113, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03550820
Lead sponsor
National Hospital Organization Minami Kyoto Hospital
Responsible party
Sponsor
First posted
Jun 8, 2018
Start date
May 1, 2018
Primary completion
Dec 27, 2021
Completion
Dec 27, 2021
Last update
Dec 28, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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