UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034958 |
|---|---|
| Receipt number | R000039858 |
| Scientific Title | The effects of spontaneous dehydration via overnight on cerebral circulation |
| Date of disclosure of the study information | 2018/11/21 |
| Last modified on | 2021/02/18 11:36:22 |
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Basic information
Public title
The effects of spontaneous dehydration via overnight on cerebral circulation
Acronym
Dehydration and Cerebral circulation
Scientific Title
The effects of spontaneous dehydration via overnight on cerebral circulation
Scientific Title:Acronym
Dehydration and Cerebral circulation
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the effects of spontaneous dehydration via overnight on cerebral circulations.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cerebral autoregulation after spontaneous dehydration via overnight.
Key secondary outcomes
cerebral blood flow, arterial blood pressure, heart rate, stroke volume, respiratory condition, cerebral blood volume, cerebral metabolism, intracranial pressure, and cardiac circulation.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
spontaneous dehydration protocol.
Interventions/Control_2
Control protocol.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adult consented to participate in this study.
Key exclusion criteria
1) Not satisfy selection criteria noted above.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Ken-ichi |
| Middle name | |
| Last name | Iwasaki |
Organization
Nihon University School of Medicine
Division name
Division of Hygiene, Department of Social Medicine
Zip code
173-8610
Address
30-1, Oyaguchi-Kamimachi, Itabashi-ku, Tokyo
TEL
03-3972-8111
iwasaki.kenichi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Yojiro |
| Middle name | |
| Last name | Ogawa |
Organization
Nihon University School of Medicine
Division name
Division of Hygiene, Department of Social Medicine
Zip code
173-8610
Address
30-1, Oyaguchi-Kamimachi, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
ogawa.yojiro@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The institutional review board of Nihon University School of Medicine
Address
30-1, Oyaguchi-Kamimachi, Itabashi-ku, Tokyo
Tel
03-3972-8111
med.kenjim@nihon-u.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
| 2018 | Year | 11 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
Results
Decreases in body weight and increases in hematocrit and hemoglobin concentration were significantly larger with overnight fasting than control conditions. Percentage changes in plasma volume were significantly larger with overnight fasting (-9.0%) than with the control protocol (-4.5%). Transfer function gain in the low-frequency range showed different changes between fasting and control conditions . The gain increased significantly with overnight fasting.
Results date posted
| 2020 | Year | 04 | Month | 23 | Day |
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
| 2018 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 21 | Day |
Last modified on
| 2021 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039858
