UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030869
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email okeiko@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035242

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.