UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055028 |
|---|---|
| Receipt number | R000046685 |
| Scientific Title | Evaluation of physical function and prognosis of IBD patients with hospitalization |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2024/07/20 11:06:18 |
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Basic information
Public title
Evaluation of physical function and prognosis of IBD patients with hospitalization
Acronym
Evaluation of physical function and prognosis of IBD patients with hospitalization
Scientific Title
Evaluation of physical function and prognosis of IBD patients with hospitalization
Scientific Title:Acronym
Evaluation of physical function and prognosis of IBD patients with hospitalization
Region
| Japan |
Condition
Condition
inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, the number of patients with inflammatory bowel disease (IBD) has been increasing in Japan, and the development of treatments, including biological agents, has been progressing. However, many patients with treatment-refractory IBD still suffer from malnutrition, and some reports indicate that loss of muscle mass and sarcopenia are predictive factors for surgery. The purpose of this study was to evaluate whether treatment is associated with sarcopenia in IBD patients and the impact of their muscle loss on prognostic factors associated with IBD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in the presence or absence of sarcopenia and its associated factors (muscle mass, muscle strength, physical function, and biomarker values) due to hospitalization
Key secondary outcomes
Assessment of disease activity, relapse rates, and surgical rates,
Correlation of sarcopenia and related factors with disease activity, relapse rate, and surgical rate
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inpatients with IBD or Inpatients with no pre-existing medical conditions
Key exclusion criteria
a) Patients with the following cardiac diseases
1) Patients with congestive heart failure of NYHA class 3 or higher
2) Patients with poorly controlled hypertension
b) Patients with serious and active infections (excluding HBV and HCV)
c) Patients who have undergone highly invasive surgery within 4 weeks prior to the start of this study
d) Pregnant, lactating women and patients who may or intend to become pregnant
e) Patients with substance abuse or other health, psychological, or social conditions that would interfere with their participation in this study and the evaluation of its results.
f) Any other situation that may compromise patient safety in the conduct of this study or that is deemed difficult to comply with the study protocol.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Miyazaki |
Organization
Osaka Medical and Pharmaceutical University
Division name
2nd Department of Internal Medicine
Zip code
5698686
Address
2-7Daigaku -machi, Takatsuki, Osaka
TEL
0726831221
takako.miyazaki@ompu.ac.jp
Public contact
Name of contact person
| 1st name | TAKAKO |
| Middle name | |
| Last name | Miyazaki |
Organization
Osaka Medical and Pharmaceutical University
Division name
2nd Department of Internal Medicine
Zip code
5698686
Address
2-7Daigaku -machi, Takatsuki, Osaka
TEL
0726831221
Homepage URL
takako.miyazaki@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee of Osaka Medical and Pharmaceutical University
Address
2-7Daigaku -machi, Takatsuki, Osaka
Tel
0726831221
rinri@ompu.ac.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
大阪医科薬科大学病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In Patients with IBD who are admitted to our gastroenterology department or attend outpatient clinics will be evaluated by measuring (1) basic information, (2) physical measurements, (3) assessment of frailty and sarcopenia, (4) muscle strength, (5) muscle mass, (6) physical function, (7) blood tests, and (8) Disease activity will be measured and evaluated at admission, at discharge, and initially (2 weeks to 1 month), 3 months, and 12 months after discharge.
Management information
Registered date
| 2024 | Year | 07 | Month | 20 | Day |
Last modified on
| 2024 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046685
