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Completed

NCT Number: NCT03550820

Energy Metabolism for the Patients With Pulmonary Mycobacterium Avium Complex

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.

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Key information

Conditions

Pulmonary MAC Body Weight Emaciation Energy Metabolism Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Hospital Organization Minami Kyoto Hospital

Jōyō, Kyoto, 610-0113, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with pulmonary MAC.

Exclusion criteria

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

National Hospital Organization Minami Kyoto Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 8, 2018
Registry last updated
Dec 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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