A Randomized trial to assess the effects of hydrogen-rich dissolution water for patients with impaired glucose tolerance or impaired fasting glucose

UMIN ID: UMIN000001329

Registered date:21/08/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Impaired glucose tolerance or impaired fasting glucose
• Date of first enrollment: 2008/07/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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)

Outcome(s)

Primary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Kyoto Prefectural University of medicine
• Source(s) of Monetary Support: Public Health Research Foundation