Unique ID issued by UMIN | UMIN000027143 |
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Receipt number | R000031106 |
Scientific Title | Long-term intake experiment of D-psicose for type 2 diabetic patients |
Date of disclosure of the study information | 2017/04/26 |
Last modified on | 2018/10/31 14:50:33 |
Long-term intake experiment of D-psicose for type 2 diabetic patients
Long-term intake experiment of D-psicose for type 2 diabetic patients
Long-term intake experiment of D-psicose for type 2 diabetic patients
Long-term intake experiment of D-psicose for type 2 diabetic patients
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
Verify the safety of diabetic and cholesterol elevated persons when 5 g of D - psicose is continuously ingested for 12 months.
Safety
Evaluate the fluctuation of the value of LDL-C before and after administration of D-psicose
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Ingestion of the test product for 12 months
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1.fasting blood glucose level 126 mg / dL or more or HbA 1 c (NGSP) 6.5% or more
2. LDL-C high price person (LDL-C 120 mg / dL or more and less than 160 mg / dL)
3. Persons who are taking medication for treating diabetes or who are administering insulin
1.Patients falling under D-psicose administration contraindications
2.Patients taking oral administration of HMG-CoA reductase inhibitor
3.Patients participating in other clinical trials
4.Pregnant women, maternity women, lactating women or women with the possibility of pregnancy
5.Patients who have poor glycemic control with HbA1c> 8%
6.Patients who have severe renal dysfunction (serum creatinine value> 1.5 mg / dl)
7.Patients with other serious complications
8.Other patients judged inappropriate as judged by doctors
60
1st name | |
Middle name | |
Last name | Koji murao |
Kagawa University
department of endocrinology and metabolism
1750-1 Ikenobe,Miki-cho,Kita-gun,Kagawa
087-891-2230
labmed@med.kagawa-u.ac.jp
1st name | |
Middle name | |
Last name | Koji murao |
Kagawa University
department of endocrinology and metabolism
1750-1 Ikenobe,Miki-cho,Kita-gun,Kagawa
087-891-2230
labmed@med.kagawa-u.ac.jp
Kagawa University
Matsutani Chemical Industry Co., Ltd.
Profit organization
NO
2017 | Year | 04 | Month | 26 | Day |
Unpublished
Completed
2017 | Year | 03 | Month | 07 | Day |
2017 | Year | 03 | Month | 07 | Day |
2018 | Year | 09 | Month | 13 | Day |
2018 | Year | 10 | Month | 31 | Day |
2018 | Year | 10 | Month | 31 | Day |
2018 | Year | 10 | Month | 31 | Day |
2017 | Year | 04 | Month | 26 | Day |
2018 | Year | 10 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031106
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