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Recruitment status Completed
Unique ID issued by UMIN UMIN000006624
Receipt No. R000007585
Scientific Title Study of the effect of modification of slow wave sleep by hypnotics on glucose tolerance in healthy male volunteers
Date of disclosure of the study information 2011/10/28
Last modified on 2012/10/29

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Basic information
Public title Study of the effect of modification of slow wave sleep by hypnotics on glucose tolerance in healthy male volunteers
Acronym Study of the effect of modification of slow wave sleep by hypnotics on glucose tolerance in healthy male volunteers
Scientific Title Study of the effect of modification of slow wave sleep by hypnotics on glucose tolerance in healthy male volunteers
Scientific Title:Acronym Study of the effect of modification of slow wave sleep by hypnotics on glucose tolerance in healthy male volunteers
Region
Japan

Condition
Condition healthy male volunteers
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of triazolam and zolpidem tartrate on the relation of slow wave sleep and next day's glucose tolerance by PSG and OGGT in healthy volunteers.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PSG
glucose tolerance
Key secondary outcomes AHI,3%ODI, PLMI
PVT, DSST
R-R interval, LF, HF, LF/HF, active mass
LARS, KSS, SMH

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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
Medicine
Interventions/Control_1 oral administartion of triazolam
Interventions/Control_2 oral administartion of zolpidem tartrate
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
40 years-old >
Gender Male
Key inclusion criteria 1)Ability to understand and willing to sign the informed consent.
2)Japanese healthy male subjects age 20 to 40 years of age
3)A body mass index(BMI)between 18 and 30 kg/m2.
4)Healthy subject as determined by medical history, physical examination, ECGs, and clinical laboratory tests.
Key exclusion criteria 1)Any hypersensitivities to triazolam and or zolpidem tartrate.
2)Any subject with hepatic or renal
disease requiring treatment.
3)QT prolongation over 460 ms on ECG.
4)Use of medicine, health product including Saint John's wort 7 days before pre-dose.
5)Intake of fruit food and drink including grapefruit juice, orange juice or apple juice from 7 days before pre-dose.
6)Participation to any other clinical reseach in the past 3 months.
7)Donating over 200 ml of blood in the past 1 month or over 400ml of blood in the past 3 months.
8)Positive tests of serological reaction for syphilis, HIV antigen and antibody, HBs antigen or HCV antibody.
9)Drug abuse or positive drug screening.
10)Anyone known to have a sleep disorder including insomnia, sleep apnea syndrome or restless legs syndrome in the past 3 months.
11)Use of medicine influences sleep
including hypnotic drug,psychotropic drug
or nonprescription sleep aid
in the past 3 months.
12)any subjects with abnormal glucose level or HbA1c.
13)Any condition that, in the opinion of the investigator, would make the patient unsuitable for the study.
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirokuni Tagaya
Organization Kitasato University
Division name School of Allied Health Sciences
Zip code
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kitasato University
Division name School of Allied Health Sciences
Zip code
Address
TEL
Homepage URL
Email tagaya@kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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
2011 Year 10 Month 28 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
2011 Year 10 Month 14 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 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
2011 Year 10 Month 28 Day
Last modified on
2012 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007585


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