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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016161
Receipt No. R000018756
Scientific Title Efficacy of "American Sunflowers Potato" on Improvement of type2 Diabetes and its Safety.
Date of disclosure of the study information 2015/01/15
Last modified on 2017/07/11

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Basic information
Public title Efficacy of "American Sunflowers Potato" on Improvement of type2 Diabetes and its Safety.
Acronym ASPMD trial
Scientific Title Efficacy of "American Sunflowers Potato" on Improvement of type2 Diabetes and its Safety.
Scientific Title:Acronym ASPMD trial
Region
Japan

Condition
Condition Type2 Diabetes
Classification by specialty
Medicine in general Gastroenterology Endocrinology and Metabolism
Hematology and clinical oncology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The main purpose of the study is to verify the effect on the blood glucose levels of mild diabetic patients by taking ASP supplements. Secondarily, to verify the impact on body weight and lipid metabolism system and the vascular system.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HbA1c
Insulin
Fasting blood sugar
HOMA-R
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Mild diabetic patients (n=14) eat ASP supplements before every meal during 12 weeks.
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. 23<=BMI<30
2. Patients with HbA1c(6.0%-8.0%) who have received a diagnosis of diabetes and received either diet, exercise or drug therapy. Alternatively, Patient who have never received a diagnosis of diabetes with corresponding to the items below
- HbA1c value:6.5%-8.0%
-Fasting glucose:126mg/dl
or more (or more at any time blood glucose level 200mg / dl)
3. Patients planned to maintain the dose of current therapies and therapeutic agents during the study period
Key exclusion criteria 1.Patients with a history of heart failure, such as myocardial infarction and
2.Exclude by disease, etc.
(Liver disease, kidney disease, who complications of cerebrovascular disease corresponds to grade 3 of severity classification criteria of side effects such as drug)
3.Patients requiring the use of insulin in the treatment of primary disease
4.Use supplements that contain the same components as American San Flowers potato
Use supplements blood sugar reducing effect is assumed
5.Patients with allergy symptoms caused by drugs and test article-related food
6. pregnant and lactating. or a person likely to become pregnant during the study period
Target sample size 14

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Nakamura
Organization Kunitachi Sakura Hospital
Division name Director of the Hospital
Zip code
Address 1-19-10 Higashi, Kunitachi-City, Tokyo, 186-0002
TEL 042-577-1011
Email kunitachisakura01@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tomomi Suga
Organization imeQ.Inc
Division name Pharmaceutical Division
Zip code
Address 2-14-6 Nishi-waseda, Sinjyuku-ku, Tokyo. 169-0075
TEL 03-6205-6222
Homepage URL
Email t-suga@imeq.co.jp

Sponsor
Institute imeQ Co.Ltd.
Institute
Department

Funding Source
Organization AUTOBAHN Inc.
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
2015 Year 01 Month 15 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 Completed
Date of protocol fixation
2014 Year 12 Month 11 Day
Date of IRB
Anticipated trial start date
2014 Year 12 Month 17 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
2015 Year 01 Month 08 Day
Last modified on
2017 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018756

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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