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Energy Metabolism for the Patients With Pulmonary Mycobacterium Avium Complex

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date May 26, 2018
First Posted Date June 8, 2018
Last Update Posted Date October 29, 2019
Actual Study Start Date May 1, 2018
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 26, 2018)
Relation between energy balance and pulmonary MAC severity [ Time Frame: Three years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 26, 2018)
  • Relation between inflammation (CRP et.) and pulmonary MAC severity [ Time Frame: Three years ]
  • Relation between bone mineral density and pulmonary MAC severity [ Time Frame: Three years ]
  • Relation between hormone secretion and pulmonary MAC severity [ Time Frame: Three years ]
  • Relation between pulmonary function and pulmonary MAC severity [ Time Frame: Three years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Energy Metabolism for the Patients With Pulmonary Mycobacterium Avium Complex
Official Title Energy Metabolism for the Patients With Pulmonary Mycobacterium Avium Complex
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood samples (serum, plasma)
Sampling Method Probability Sample
Study Population Petients with pulmonary MAC
Condition
  • Pulmonary MAC
  • Energy Metabolism
  • Emaciation
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: October 25, 2019)
105
Original Estimated Enrollment
 (submitted: May 26, 2018)
150
Estimated Study Completion Date May 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects with pulmonary MAC.

Exclusion Criteria:

  • Subjects with severe cardiovascular disease, diabetes, neurological disease, renal failure, endocrine disease and malignant neoplasm.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03550820
Other Study ID Numbers 28-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Hospital Organization Minami Kyoto Hospital
Study Sponsor National Hospital Organization Minami Kyoto Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account National Hospital Organization Minami Kyoto Hospital
Verification Date October 2019