UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056000 |
|---|---|
| Receipt number | R000063995 |
| Scientific Title | Evaluation of the Impact of Bariatric Surgery on Bronchial Asthma Control in Obesity-Related Bronchial Asthma Patients: A Prospective Observational Study |
| Date of disclosure of the study information | 2024/10/30 |
| Last modified on | 2024/10/30 20:42:07 |
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Basic information
Public title
Evaluation of the Impact of Bariatric Surgery on Bronchial Asthma Control in Obesity-Related Bronchial Asthma Patients: A Prospective Observational Study
Acronym
Evaluation of the Impact of Bariatric Surgery on Bronchial Asthma Control in Obesity-Related Bronchial Asthma Patients: A Prospective Observational Study
Scientific Title
Evaluation of the Impact of Bariatric Surgery on Bronchial Asthma Control in Obesity-Related Bronchial Asthma Patients: A Prospective Observational Study
Scientific Title:Acronym
Evaluation of the Impact of Bariatric Surgery on Bronchial Asthma Control in Obesity-Related Bronchial Asthma Patients: A Prospective Observational Study
Region
| Japan |
Condition
Condition
bronchial asthma, obese, obesity-related bronchial asthma.
Classification by specialty
| Pneumology | Clinical immunology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate the impact of Bariatric Surgery on bronchial asthma control in patients with obesity-related bronchial asthma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pre- and postoperative change in ACT score (3, 6, and 12 months postoperatively)
Key secondary outcomes
Pre- and postoperative change in FEV1 (3, 6, and 12 months postoperatively)
Pre- and post-operative change in NO levels (3, 6, and 12 months post-operatively)
ACT evaluation of asthma phenotype Type 2 inflammation group and Non-Type 2 inflammation group (3,6,12 months postoperatively)
Number of Rescue SABA use based on ACT
(evaluated based on ACT score data) (3,6,12 months post-op)
%TWL, %EWL and ACT evaluation (3,6,12 months postoperatively)
Body composition values and ACT evaluation (3, 6, and 12 months postoperatively)
ACT evaluation with and without CPAP intervention and compliance evaluation group (3, 6, and 12 months postoperatively)
Pre- and postoperative changes in adiponectin and leptin levels (12 months postoperatively)
The above study was performed with and without the use of GLP-1
The above study excluding patients with Brinkman Index 400 or higher
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
18 years of age or older
Ongoing bronchial asthma treatment at the time of Bariatric Surgery
First Bariatric Surgery
Key exclusion criteria
Pacemaker patients
Patients with Nt-pro BNP 125ng/dl or higher
Severe psychiatric illness
Patients with cancer
Obesity due to endocrine disorders or drugs (secondary obesity)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | MITSUHIRO |
| Middle name | |
| Last name | SUMITANI |
Organization
Chibune General Hospital, Aijinkai Healthcare Corporaion
Division name
Department of Sleep, Respiratory and Rehabilitation Medicine
Zip code
555-0034
Address
3-2-39,Fukumachi, Nishiyodogawa-ku, Osaka JAPAN
TEL
06-6471-9541
sumytany@nifty.com
Public contact
Name of contact person
| 1st name | MITSUHIRO |
| Middle name | |
| Last name | SUMITANI |
Organization
Chibune General Hospital, Aijinkai Healthcare Corporaion
Division name
Department of Sleep, Respiratory and Rehabilitation Medicine
Zip code
555-0034
Address
3-2-39,Fukumachi, Nishiyodogawa-ku, Osaka JAPAN
TEL
06-6471-9541
Homepage URL
sumytany@nifty.com
Sponsor or person
Institute
Chibune General Hospital, Aijinkai Healthcare Corporaion
Institute
Department
Personal name
Funding Source
Organization
Chibune General Hospital, Aijinkai Healthcare Corporaion
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chibune General Hospital, Aijinkai Healthcare Corporaion
Address
3-2-39,Fukumachi, Nishiyodogawa-ku, Osaka JAPAN
Tel
06-6471-9541
sumytany@nifty.com
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
In the weight loss surgery list of patients scheduled for weight loss and metabolism improvement surgery for severe obesity, patients who checked the history of bronchial asthma in the preoperative questionnaire sheet and patients who are currently being treated for bronchial asthma in the list of medications to be brought, are selected and examined by the respiratory medicine department, Collect electronic medical record information.
Management information
Registered date
| 2024 | Year | 10 | Month | 30 | Day |
Last modified on
| 2024 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063995
