UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000006624
Receipt number	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 15:00:39

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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

healthy male volunteers

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

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

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

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

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

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 or person

Institute

Kitasato University

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007585

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name