UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001329
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

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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 or person

Institute

Kyoto Prefectural University of medicine

Institute

Department

Personal name



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

Value
https://center6.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