UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030933 |
|---|---|
| Receipt number | R000034580 |
| Scientific Title | Pleiotropic effects of mazindol against gastrointestinal and appetite control peptides |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2018/05/21 15:16:29 |
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Basic information
Public title
Pleiotropic effects of mazindol against gastrointestinal and appetite control peptides
Acronym
Pleiotropic effects of mazindol
Scientific Title
Pleiotropic effects of mazindol against gastrointestinal and appetite control peptides
Scientific Title:Acronym
Pleiotropic effects of mazindol
Region
| Japan |
Condition
Condition
Obesity diseases
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the action of mazindol on obesity-related factors such as incretin, adipocytokines, FGF19, and FGF21, which has attracted attention in recent years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of body weight and body composition before and after 3 month use of mazindol, and the differences of body weight and body composition using or not using mazindol
Key secondary outcomes
1)Insulin, incretin, glucagon, gastrointestinal peptide,FGF19, FGF21 secretion capacity and pattern by glucagon tolerance test
2)Changes in urine glucose, urine protein, adipocytokines, hs-CRP, uric acid, basal metabolism, blood pressure, blood pressure pulse wave examination before and after use of mazindol
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In the mazindol administration group, mazindol is gradually increased from 0.5 mg/day to 1.5 mg/day and administered for 3 months after 3 to 6 months from the start of the test.
Interventions/Control_2
In the regular treatment group, Mazindol do not be use but continue meal, exercise, behavioral therapy.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients aged 20 to 70 years old with obesity disease. BMI is 35 or more.
Key exclusion criteria
1.Patient who cannnot regulary visit h ospital
2.Patients with anxiety / depression / abnormal excitement or patients with psychiatric disorders such as schizophrenia
3. Patient who judged inappropriate due to the complications and treatment by attending doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Ueno |
Organization
University of Miyazaki , fuculty of med icine
Division name
Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine
Zip code
Address
5200 Kihara, Kiyotake, Miyazaki, Miya zaki, Japan
TEL
0985-85-2695
intron@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Ueno |
Organization
University of Miyazaki , fuculty of med icine
Division name
Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine,
Zip code
Address
5200 Kihara, Kiyotake, Miyazaki, Miya zaki, Japan
TEL
0985-85-2695
Homepage URL
intron@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki , fuculty of med icine, Neurology, Respirology, Endocri nology and Metabolism, Department o f Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
宮崎大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | 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
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | 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
| 2018 | Year | 01 | Month | 22 | Day |
Last modified on
| 2018 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034580
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
