UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027557 |
|---|---|
| Receipt number | 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 | 2023/06/06 15:33:36 |
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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 | Makito |
| Middle name | |
| Last name | Tanabe |
Organization
Fukuoka University Hospital
Division name
Department of Endocrinology and Diabetes Mellitus
Zip code
8140180
Address
7-45-1, Nanakuma, Jonan-ku, Fukuoka, Japan
TEL
092-801-1011
mtanabe@live.jp
Public contact
Name of contact person
| 1st name | Makito |
| Middle name | |
| Last name | Tanabe |
Organization
Fukuoka University Hospital
Division name
Department of Endocrinology and Diabetes Mellitus
Zip code
8140180
Address
7-45-1, Nanakuma, Jonan-ku, Fukuoka, Japan
TEL
092-801-1011
Homepage URL
mtanabe@live.jp
Sponsor or person
Institute
Fukuoka University Hospital
Institute
Department
Personal name
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
Fukuoka University Hospital
Address
7-45-1, Nanakuma, Jonan-ku, Fukuoka, Japan
Tel
092-801-1011
mtanabe@live.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
| 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
Terminated
Date of protocol fixation
| 2017 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2017 | Year | 05 | Month | 31 | Day |
Last modified on
| 2023 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031592
