UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045128 |
|---|---|
| Receipt number | R000051558 |
| Scientific Title | The influence of energy malnutrition on muscle mass and physical function in patients with chronic obstructive pulmonary disease (COPD) |
| Date of disclosure of the study information | 2021/08/14 |
| Last modified on | 2024/02/12 10:45:16 |
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Basic information
Public title
An investigation of early starvation in COPD patients and the applicability of LES (Late evening snack)
Acronym
Starvation in COPD Patients
Scientific Title
The influence of energy malnutrition on muscle mass and physical function in patients with chronic obstructive pulmonary disease (COPD)
Scientific Title:Acronym
Energy malnutrition in chronic obstructive pulmonary disease
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease (COPD)
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the factors associated with energy malnutrition in patients with stable COPD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Energy malnutrition
Key secondary outcomes
Respiratory functions
Muscle mass (CT)
Physical functions
Nutrition status
Anthropometry
Activities of daily living (ADL)
Laboratory determinations
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Male outpatients with COPD who
(1) were 20 years of age or older;
(2) able to hold standing position and walk;
(3) had undergone a biochemical examination and CT scans of the Th12 level.
Key exclusion criteria
Patients with COPD who
(1) had a using home oxygen;
(2) had a severe liver function;
(3) had severe diabetes;
(4) suffered from inflammatory, endocrine, or gastrointestinal diseases;
(5) had other malignancies, malabsorption, or motor disorders.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Tomita |
Organization
JCHO Saga Central Hospital
Division name
Department of Rehabilitation
Zip code
849-8522
Address
3-8-1, Hyogo-Minami, Saga City, Saga, Japan
TEL
+81952285311
sp4u7m99@ray.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Tomita |
Organization
JCHO saga central hospital
Division name
Department of Rehabilitation
Zip code
849-8522
Address
3-8-1, Hyogo-Minami, Saga City, Saga, Japan
TEL
+81952285311
Homepage URL
sp4u7m99@ray.ocn.ne.jp
Sponsor or person
Institute
JCHO saga central hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kurume University Graduate School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
JCHO Saga Central Hospital Ethics Review Committee
Address
3-8-1, Hyogo-Minami, Saga City, Saga, Japan
Tel
+81952285311
main@saga.jcho.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
JCHO佐賀中部病院（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 14 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2072-6643/14/13/2596
Publication of results
Partially published
Result
URL related to results and publications
https://www.mdpi.com/2072-6643/14/13/2596
Number of participants that the trial has enrolled
56
Results
Energy malnutrition was observed in 43% of patients with stable COPD. In logistic regression analysis, the independent factors associated with energy malnutrition were tidal volume (VT) [OR 0.99; 95% CI 0.985-0.998; P=0.015], Th12 erector spinae muscle cross-sectional area SMI (Th12ESMSMI) [OR 0.71; 95% CI 0.535-0.946; P=0.019].
Results date posted
| 2021 | Year | 08 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 06 | Month | 21 | Day |
Baseline Characteristics
Between October 2020 and March 2021, male COPD patients attending JCHO Saga Central Hospital.
Participant flow
65 consecutive patients out of 163 outpatient male COPD patients who attended Japan Community Health Care Organization Saga Central Hospital between October 2020 and March 2021, who met the following selection and exclusion criteria.
Selection Criteria
Patients who meet all of the following criteria will be selected
(1) Male outpatients 20 years of age or older
(2) Able to stand and walk, and
(3) Patients who have undergone blood biochemistry tests and chest CT scan.
Exclusion Criteria
Patients who meet any of the following criteria will be excluded from the study
(1) Patients using home oxygen
(2) Patients with severe liver function
(3) Patients with severe diabetes mellitus
(4) Patients with inflammatory disease, endocrine system disease, or digestive system disease
(5) Persons with other malignant tumors or musculoskeletal disorders.
Adverse events
None
Outcome measures
The patient's medical information (metabolic measurement data, height and weight, medical history, medical history, blood data, CT images, physical function evaluation, and body composition data) obtained in the usual medical examination will be used to evaluate the patient over time. For metabolic measurements, an indirect calorimeter will be used to analyze expiratory gas in the supine resting position, and for CT images, muscle area at the 12th thoracic vertebra and 3rd lumbar vertebra will be measured using image analysis software to calculate the skeletal muscle index. The physical function assessment is used to plan and modify rehabilitation programs. Questionnaires are also used to assist in planning and modifying rehabilitation programs.
Translated with www.DeepL.com/Translator (free version)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2027 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 11 | Month | 30 | Day |
Other
Other related information
Fifty-six male outpatients with COPD were included in the study. Respiratory quotient (RQ), an index of energy malnutrition, was calculated by expiratory gas analysis using an indirect calorimeter. In this study, RQ 0.85 less was defined as energy malnutrition group and RQ 0.85 more as non-energy malnutrition group. The independent factors related to the presence of energy malnutrition were extracted by logistic regression analysis, and the related factors were profiled by decision tree analysis. In addition, cutoff values for discriminating the presence of energy malnutrition were calculated by receiver operating characteristic analysis. In addition, impact of energy malnutrition on prognosis will be analyzed by survival time analysis and Log rank test and Cox proportional hazards model.
Management information
Registered date
| 2021 | Year | 08 | Month | 11 | Day |
Last modified on
| 2024 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051558
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/08/12 | 佐賀中部病院用 研究計画書 Energy malnutrition in COPD.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
