UMIN-CTR Clinical Trial

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
Email	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
Email	ogawa.yojiro@nihon-u.ac.jp

Sponsor
Institute	Nihon University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039858