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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027557
Receipt No. R000031592
Scientific Title Weight reduction by mazindol in morbid obesity with or without type 2 diabetes mellitus
Date of disclosure of the study information 2017/08/01
Last modified on 2017/05/31

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Basic information
Public title Weight reduction by mazindol in morbid obesity with or without type 2 diabetes mellitus
Acronym Weight reduction by mazindol in morbid obesity
Scientific Title Weight reduction by mazindol in morbid obesity with or without type 2 diabetes mellitus
Scientific Title:Acronym Weight reduction by mazindol in morbid obesity
Region
Japan

Condition
Condition obesity disease
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate weight reduction by mazindol in morbid obesity with or without type 2 diabetes mellitus
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Weight reduction rate in 3 months' administration of mazindol, with or without the use of SGLT2 inhibitor
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 administration of mazindol: 0.5mg/day for 2 weeks, followed by 1mg/day for 2 weeks and 1.5mg/day for 2 months
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
65 years-old >
Gender Male and Female
Key inclusion criteria morbid obesity(BMI:35 or more)
Key exclusion criteria Patients with contraindication for administration of mazindol or SGLT2 inhibitor
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makito Tanabe
Organization Fukuoka University Hospital
Division name Department of Endocrinology and Diabetes Mellitus
Zip code
Address 7-45-1, Nanakuma, Jonan-ku, Fukuoka, Japan
TEL 092-801-1011
Email mtanabe@live.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makito Tanabe
Organization Fukuoka University Hospital
Division name Department of Endocrinology and Diabetes Mellitus
Zip code
Address 7-45-1, Nanakuma, Jonan-ku, Fukuoka, Japan
TEL 092-801-1011
Homepage URL
Email mtanabe@live.jp

Sponsor
Institute Fukuoka University Hospital
Institute
Department

Funding Source
Organization Fukuoka University Hospital
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
Address
Tel
Email

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
2017 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
2017 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 31 Day
Last modified on
2017 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031592

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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