UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030869 |
|---|---|
| Receipt number | R000035242 |
| Scientific Title | The safety and glycolipid metabolism efficacy of plant extract essence in obese patients with type 2 diabetes mellitu |
| Date of disclosure of the study information | 2018/01/18 |
| Last modified on | 2018/01/18 08:52:55 |
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Basic information
Public title
The safety and glycolipid metabolism efficacy of plant extract essence in obese patients with type 2 diabetes mellitu
Acronym
SAGMEP2
Scientific Title
The safety and glycolipid metabolism efficacy of plant extract essence in obese patients with type 2 diabetes mellitu
Scientific Title:Acronym
SAGMEP2
Region
| Japan |
Condition
Condition
type2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety of plant extract essence in obese patients with type 2 diabetes mellitu
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety
Key secondary outcomes
Improvement of lipid metabolism
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Orally given eight tablet of Metabarrier premium S(R) daily for three 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Type 2 diabetes mellitus, BMI >25, HbA1c => 6.5%
2. Patients with normal liver and kidney function
3. Patients who do not take alpha-glucosidase inhibitors
4. Patients who can provide their written consent for participation of this study
Key exclusion criteria
1.Patients with history of drug allergies or food allergies
2.Patients who take glycometabolism, lipid metabolism or blood pressure improvement supplements
3. Patients who take alpha-glucosidase inhibitors
4.Patients with high consumption of alcohol and a history of heavy smoking.
5. Patients with irregular eating patternsintake
6.Women with during pregnancy , nursing, or pregnant likelihood
7.Inadequte patient judged by doctor
8.Unable to obtain informed consent to this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiko Ogawa |
Organization
Kanazawa University Hospital
Division name
Japanese-Traditional (Kampo) Medicine
Zip code
Address
13-1 Takaramachi, Kanazawa-city, Ishikawa 920-8641
TEL
076-265-2918
okeiko@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Ogawa |
Organization
Kanazawa University Hospital
Division name
Japanese-Traditional (Kampo) Medicine
Zip code
Address
13-1 Takaramachi, Kanazawa-city, Ishikawa 920-8641
TEL
076-265-2918
Homepage URL
okeiko@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Fujifilm Corporation
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 18 | 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
| 2018 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | 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 | 18 | Day |
Last modified on
| 2018 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035242
| 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 |
