Unique ID issued by UMIN | UMIN000001329 |
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Receipt number | R000001614 |
Scientific Title | A Randomized trial to assess the effects of hydrogen-rich dissolution water for patients with impaired glucose tolerance or impaired fasting glucose |
Date of disclosure of the study information | 2008/08/21 |
Last modified on | 2010/12/20 10:03:34 |
A Randomized trial to assess the effects of hydrogen-rich dissolution water for patients with impaired glucose tolerance or impaired fasting glucose
A Randomized trial to assess the effects of hydrogen-rich dissolution water for patients with impaired glucose tolerance or impaired fasting glucose (CSP-LD04)
A Randomized trial to assess the effects of hydrogen-rich dissolution water for patients with impaired glucose tolerance or impaired fasting glucose
A Randomized trial to assess the effects of hydrogen-rich dissolution water for patients with impaired glucose tolerance or impaired fasting glucose (CSP-LD04)
Japan |
Impaired glucose tolerance or impaired fasting glucose
Medicine in general | Endocrinology and Metabolism |
Others
NO
To examine whether hydrogen dissolution water is better than normal water(placebo) for glucose tolerance improvement in patients with impaired glucose tolerance or impaired fasting glucose
Safety,Efficacy
Confirmatory
Phase II,III
1)75gOGTT(glucose);0 minute (in the fasting state),30,60,90 minutes later after loading
2)Delta AUC(0-120min);The difference of the area under the plasma glucose concentration before and after administration
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Food |
The patients will be intervened with hydrogen dissolution water group (hydrogen group) 200ml every three times in a day in 3 months (84days)
The patients will be intervened with normal water group (placebo group) 200ml every three times in a day in 3 months (84days)
20 | years-old | <= |
70 | years-old | > |
Male and Female
1) Patients who are abele to give written informed consent
2) FBS is over 100mg/dl and under 126mg/dl in registration
3) Age is over 20 years and less than 80 years
4) Type of practice: outpatient department
5) Patients are able to do the following things in this trial - getting good compliance with consuming investigational food and coming to hospital, and writing the diary and the questionnaire accurately by themselves
1) Patients who have receive drug treatment for diabetes
2) Patients with the diseases which have possibility with impaired glucose tolerance
3) Patients with serious liver or kidney damage
4) Patients with serious heart disease or cerebrovascular disorders
5) Patients with serious disease in pancreas or blood disease
6) Patients with malignant tumors which effect their general status or survival time
7) Patients who are in pregnancy, while breast-feeding, have possibilities of them, or desire pregnancy in test period
8) Patients with alcohol abuse
9) Patients who have taken part in the her clinical research within 12 weeks
10) Patients who have taken part in the her clinical research within 12 weeks
11) Patients who are inadequate, which their physicians assessed it
60
1st name | |
Middle name | |
Last name | Toshikazu Yoshikawa |
Kyoto Prefectural University of medicine
Graduate school of Medicine, department of digestive tract internal medicine
465 Kajiicho, hirokojinoboru, Kawaramachi-dori, Kamikyo-ku, Kyoto-shi, Kyoto
075-251-5591
1st name | |
Middle name | |
Last name | Comprehensive Support Project for Clinical Research Office |
Public Health Research Foundation
Comprehensive Support Project for Clinical Research Office on Lifestyle-related disease
1-1-7 Nishi-Waseda, Shinjuku-ku 169-0051
03-5287-2633
info@csp.or.jp
Kyoto Prefectural University of medicine
Public Health Research Foundation
Non profit foundation
Japan
NO
2008 | Year | 08 | Month | 21 | Day |
Unpublished
Completed
2008 | Year | 07 | Month | 03 | Day |
2008 | Year | 07 | Month | 01 | Day |
2009 | Year | 03 | Month | 01 | Day |
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2010 | Year | 05 | Month | 01 | Day |
2008 | Year | 08 | Month | 21 | Day |
2010 | Year | 12 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001614
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