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

Phase 2

• Conditions: Impaired glucose tolerance or impaired fasting glucose

• Registration Number: JPRN-UMIN000001329
• Lead Sponsor: Kyoto Prefectural University of medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)75gOGTT(glucose);0 minute (in the fasting state),30,60,90 minutes later after loading<br>2)Delta AUC(0-120min);The difference of the area under the plasma glucose concentration before and after administration