UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018182 |
|---|---|
| Receipt number | R000021058 |
| Scientific Title | Investigation for effects of hydrogen water on lipid and glucose metabolism in diabetes mellitus |
| Date of disclosure of the study information | 2015/07/03 |
| Last modified on | 2015/07/03 16:02:23 |
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Basic information
Public title
Investigation for effects of hydrogen water on lipid and glucose metabolism in diabetes mellitus
Acronym
Investigation for effects of hydrogen water on lipid and glucose metabolism in diabetes mellitus
Scientific Title
Investigation for effects of hydrogen water on lipid and glucose metabolism in diabetes mellitus
Scientific Title:Acronym
Investigation for effects of hydrogen water on lipid and glucose metabolism in diabetes mellitus
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of hydrogen water for improving lipid and glucose metabolism, oxidative stress and inflammation in patients with type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
lipid and glucose metabolism, oxidative stress and inflammation
Key secondary outcomes
1) Fasting plasma glucose, insulin, HbA1c
2) Body weight, waist circumference, body mass index
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Group A: Drinking of hydrogen water 0.6 L/day for 3 months, following 2 months washout and drinking of control water 0.6 L/day for 3 months
Interventions/Control_2
Group B: Drinking of control water 0.6 L/day for 3 months, following 2 months washout and drinking of hydrogen water 0.6 L/day for 3 months
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes
Key exclusion criteria
1) Patients with heart failure
2) Patients with severe renal dysfunction or severe liver failure
3) Patients with electrolyte abnormality
4) Patients with hypoalbuminemia
5) Patients with severe edema
6) Dialysis patients
7) Patients with dementia
8) Patients determined to be inappropriate as a test subjected by investigators
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Aoki |
Organization
Tokyo metropolitan institute of gerontology
Division name
Biological processs of aging
Zip code
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
s-aoki@tmig.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Aoki |
Organization
Aidu chuo hospital
Division name
Internal medicine, Cardiovascular medicine
Zip code
Address
1-1 Tsuruga-machi, Aiduwakamatsu City, Fukushima
TEL
0252-25-1515
Homepage URL
s-aoki@tmig.or.jp
Sponsor or person
Institute
Tokyo metropolitan institute of gerontology
Institute
Department
Personal name
Funding Source
Organization
Melodian Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 07 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 03 | Day |
Last modified on
| 2015 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021058
