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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041014
Receipt No. R000046836
Scientific Title Study of the therapeutic effects of bariatric surgery for severe obesity
Date of disclosure of the study information 2020/08/01
Last modified on 2020/07/06

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Basic information
Public title Study of the therapeutic effects of bariatric surgery for severe obesity
Acronym Study of the therapeutic effects of bariatric surgery for severe obesity
Scientific Title Study of the therapeutic effects of bariatric surgery for severe obesity
Scientific Title:Acronym Study of the therapeutic effects of bariatric surgery for severe obesity
Region
Japan

Condition
Condition severe obesity
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to elucidate the pathology of obesity by evaluating the body composition, insulin resistance, and humoral factors before and after bariatric surgery in patients undergoing briatric surgery for severe obesity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To examine changes in insulin resistance index by glucose clamp test before and after bariatric surgery.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Glucose clamp tests are performed before bariatric surgery and 6 months after surgery.
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
65 years-old >=
Gender Male and Female
Key inclusion criteria Patients undergoing obesity reduction surgery who obtained consent to participate in the study.
Key exclusion criteria Patients who violate any of the following are excluded from this study.
1) Diabetes patients with etiology other than type 2 diabetes
2) Patients with a history of severe ketosis, diabetic coma or precoma within the past 6 months.
3) Patients with severe infections and serious trauma
4) Pregnant women or women who may be pregnant and breast-feeding patients
5) Patients with severe liver dysfunction
6) Patients with moderate or higher renal dysfunction or end-stage renal failure on dialysis
7) Patients with heart failure (NYHA classification II-IV)
8) Patients with serious mental illness
9) Patients with a history of hypersensitivity to insulin
10) Obese patients due to abnormal endocrine hormones
11) Patients treated with steroid hormones
12) Patients who are not suitable for study participation because of medical reasons
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yohei
Middle name
Last name Fujioka
Organization Tottori University Faculty of Medicine
Division name Division of Cardiovascular Medicine and Endocrinology and Metabolism
Zip code 6838504
Address 36-1, NIshi-cho, Yonago, Tottori
TEL 0859386517
Email yohei_0201@tottori-u.ac.jp

Public contact
Name of contact person
1st name Yohei
Middle name
Last name Fujioka
Organization Tottori University Faculty of Medicine
Division name Division of Cardiovascular Medicine and Endocrinology and Metabolism
Zip code 6838504
Address 36-1, NIshi-cho, Yonago, Tottori
TEL 0859386517
Homepage URL
Email yohei_0201@tottori-u.ac.jp

Sponsor
Institute Tottori University Faculty of Medicine, Division of Cardiovascular Medicine and Endocrinology and Me
Institute
Department

Funding Source
Organization Tottori University Faculty of Medicine, Division of Cardiovascular Medicine and Endocrinology and Me
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 Certified Review Board, Tottori University Hospital
Address 36-1, NIshi-cho, Yonago, Tottori
Tel 0859387021
Email cert.office@ml.med.tottori-u.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

Other administrative information
Date of disclosure of the study information
2020 Year 08 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 Preinitiation
Date of protocol fixation
2020 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 07 Month 06 Day
Last modified on
2020 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046836

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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