UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019032 |
|---|---|
| Receipt number | R000020711 |
| Scientific Title | Electrolysis hydrogen water improves insulin resistance in type 2 diabetes. |
| Date of disclosure of the study information | 2015/10/30 |
| Last modified on | 2022/03/29 10:28:07 |
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Basic information
Public title
Electrolysis hydrogen water improves insulin resistance in type 2 diabetes.
Acronym
Electrolysis hydrogen water improves insulin resistance in type 2 diabetes.
Scientific Title
Electrolysis hydrogen water improves insulin resistance in type 2 diabetes.
Scientific Title:Acronym
Electrolysis hydrogen water improves insulin resistance in type 2 diabetes.
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the follow study hypothesis. Drinking of an Electrolysis hydrogen water improves insulin resistance in type 2 diabetes mellitus.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The subjects are given an Electrolysis hydrogen water or a usual clean water, and we evaluate insulin resistance (HOMA-IR) before drinking and 3-month later.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
This study is a prospective double blind randomized control trial. The entry period of this study is one year. Subjects are type 2 diabetes mellitus patients without insulin therapy. The subjects are randomly assigned to two groups, an Electrolysis hydrogen water drinking group and a usual clean water drinking group. The subjects are given an Electrolysis hydrogen water (1,500-2,000mL/day, for 12 weeks) in an Electrolysis hydrogen water drinking group.
Interventions/Control_2
The subjects are given a usual clean water (1,500-2,000mL/day, for 12 weeks)
in a usual clean (placebo) water drinking group.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The subjects enrolled in our study are type 2 diabetes mellitus outpatients, who visit our hospitals and fulfilled the following criteria: 1) without insulin therapy 2) the HbA1c levels are less than 10 % 3) without congestive heart failure 4) Within 20-80 years old.
Key exclusion criteria
1) The age > 80 years old or < 20 years old.2) The subjects are received insulin therapy. 3) Subjects who drank electrolysis hydrogen water within two months. 4) Complicated with congestive heart failure (the BNP level > 500 pg/mL)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Ogawa |
Organization
Tohoku University Hospital
Division name
Division of Nephrology, Endocrinology and vascular medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan
TEL
022-717-7163
ogawa-s@hosp.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Ogawa |
Organization
Tohoku University Hospital
Division name
Division of Nephrology, Endocrinology and vascular medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan
TEL
022-717-7163
Homepage URL
ogawa-s@hosp.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
NIHON TRIM CO.,LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
NIHON TRIM CO.,LTD
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Hospital
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574 Japan
Tel
022-728-4105
ec@rinri.hosp.tohoku.ac.jp
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
| 2015 | Year | 10 | Month | 30 | 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
| 2015 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 16 | Day |
Last modified on
| 2022 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020711
