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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001329
Receipt No. 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

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Basic information
Public title A Randomized trial to assess the effects of hydrogen-rich dissolution water for patients with impaired glucose tolerance or impaired fasting glucose
Acronym A Randomized trial to assess the effects of hydrogen-rich dissolution water for patients with impaired glucose tolerance or impaired fasting glucose (CSP-LD04)
Scientific Title A Randomized trial to assess the effects of hydrogen-rich dissolution water for patients with impaired glucose tolerance or impaired fasting glucose
Scientific Title:Acronym A Randomized trial to assess the effects of hydrogen-rich dissolution water for patients with impaired glucose tolerance or impaired fasting glucose (CSP-LD04)
Region
Japan

Condition
Condition Impaired glucose tolerance or impaired fasting glucose
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes 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 secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 The patients will be intervened with hydrogen dissolution water group (hydrogen group) 200ml every three times in a day in 3 months (84days)
Interventions/Control_2 The patients will be intervened with normal water group (placebo group) 200ml every three times in a day in 3 months (84days)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key 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
Key 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
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshikazu Yoshikawa
Organization Kyoto Prefectural University of medicine
Division name Graduate school of Medicine, department of digestive tract internal medicine
Zip code
Address 465 Kajiicho, hirokojinoboru, Kawaramachi-dori, Kamikyo-ku, Kyoto-shi, Kyoto
TEL 075-251-5591
Email

Public contact
Name of contact person
1st name
Middle name
Last name Comprehensive Support Project for Clinical Research Office
Organization Public Health Research Foundation
Division name Comprehensive Support Project for Clinical Research Office on Lifestyle-related disease
Zip code
Address 1-1-7 Nishi-Waseda, Shinjuku-ku 169-0051
TEL 03-5287-2633
Homepage URL
Email info@csp.or.jp

Sponsor
Institute Kyoto Prefectural University of medicine
Institute
Department

Funding Source
Organization Public Health Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 08 Month 21 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2010 Year 01 Month 01 Day
Date trial data considered complete
2010 Year 01 Month 01 Day
Date analysis concluded
2010 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 08 Month 21 Day
Last modified on
2010 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001614

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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