UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016161 |
|---|---|
| Receipt number | 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 09:15:26 |
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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
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
t-suga@imeq.co.jp
Sponsor or person
Institute
imeQ Co.Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018756
| 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 |
