Unique ID issued by UMIN | UMIN000016161 |
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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 |
Efficacy of "American Sunflowers Potato" on Improvement of type2 Diabetes and its Safety.
ASPMD trial
Efficacy of "American Sunflowers Potato" on Improvement of type2 Diabetes and its Safety.
ASPMD trial
Japan |
Type2 Diabetes
Medicine in general | Gastroenterology | Endocrinology and Metabolism |
Hematology and clinical oncology |
Others
NO
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.
Safety,Efficacy
HbA1c
Insulin
Fasting blood sugar
HOMA-R
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Food |
Mild diabetic patients (n=14) eat ASP supplements before every meal during 12 weeks.
20 | years-old | <= |
Not applicable |
Male and Female
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
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
14
1st name | |
Middle name | |
Last name | Kiyoshi Nakamura |
Kunitachi Sakura Hospital
Director of the Hospital
1-19-10 Higashi, Kunitachi-City, Tokyo, 186-0002
042-577-1011
kunitachisakura01@gmail.com
1st name | |
Middle name | |
Last name | Tomomi Suga |
imeQ.Inc
Pharmaceutical Division
2-14-6 Nishi-waseda, Sinjyuku-ku, Tokyo. 169-0075
03-6205-6222
t-suga@imeq.co.jp
imeQ Co.Ltd.
AUTOBAHN Inc.
Profit organization
NO
2015 | Year | 01 | Month | 15 | Day |
Unpublished
Completed
2014 | Year | 12 | Month | 11 | Day |
2014 | Year | 12 | Month | 17 | Day |
2015 | Year | 01 | Month | 08 | Day |
2017 | Year | 07 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018756
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