UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029999
Receipt number R000034258
Scientific Title Controlled study of the effects on glucose metabolism and gut microbiome by the treatment of sleep disorders
Date of disclosure of the study information 2017/12/01
Last modified on 2022/05/23 19:22:27

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Basic information

Public title

Controlled study of the effects on glucose metabolism and gut microbiome by the treatment of sleep disorders

Acronym

correlation of sleep, glucose metabolism and gut microbiome

Scientific Title

Controlled study of the effects on glucose metabolism and gut microbiome by the treatment of sleep disorders

Scientific Title:Acronym

correlation of sleep, glucose metabolism and gut microbiome

Region

Japan


Condition

Condition

diabetes mellitus, sleep disorders

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the possible correlation among sleep rhythms disorders, gut microbiome, and glucose metabolism

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The change of gut bacterial composition, increase or decrease of each bacterial phylum

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


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

Medicine

Interventions/Control_1

To analyse and compare gut microbime and glucose metabolism before and after 3months treatment by melatonin-receptor agonist(ramelteon)

Interventions/Control_2

To analyse and compare gut microbime and glucose metabolism before and after 3months treatment by orexin receptor antagonist(suvorexant)

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

patients with type 2 diabetes and sleep disorders

Key exclusion criteria

HbA1c<6.5% or >=10%
severe liver dysfunction
severe renal dysfunction(eGFR<30)
previous cerebral infarction or myocardial infarction
pregnant or breast-feeding
hypersensitive to applicable drug
judged as inappropriate by attending physician

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Masahiro
Middle name
Last name Nishi

Organization

Wakayama Medical University

Division name

Division of Clinical Nutrition and Metabolism

Zip code

641-8509

Address

811-1 Kimiidera, Wakayama-City, Wakayama prefecture

TEL

073-441-0625

Email

mnishi@wakayama-med.ac.jp


Public contact

Name of contact person

1st name Shuhei
Middle name
Last name Morita

Organization

Wakayama Medical University

Division name

The First Department of Medicine

Zip code

641-8509

Address

811-1 Kimiidera, Wakayama-City, Wakayama prefecture

TEL

073-441-0625

Homepage URL


Email

shuhei0528@gmail.com


Sponsor or person

Institute

Wakayama Medical University

Institute

Department

Personal name



Funding Source

Organization

Wakayama Medical University

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

Research Ethics Committee of Wakayama Medical University

Address

811-1 Kimiidera, Wakayama-City, Wakayama prefecture

Tel

073-447-2300

Email

wa-rinri@wakayama-med.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

2017 Year 12 Month 01 Day


Related information

URL releasing protocol

Nothing

Publication of results

Unpublished


Result

URL related to results and publications

Nothing

Number of participants that the trial has enrolled

0

Results

The Study was stopped.

Results date posted

2022 Year 05 Month 20 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The Study was stopped.

Participant flow

The Study was stopped.

Adverse events

Nothing

Outcome measures

The Study was stopped.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2017 Year 11 Month 13 Day

Date of IRB

2017 Year 11 Month 13 Day

Anticipated trial start date

2017 Year 12 Month 01 Day

Last follow-up date

2021 Year 02 Month 11 Day

Date of closure to data entry

2021 Year 02 Month 11 Day

Date trial data considered complete

2021 Year 02 Month 11 Day

Date analysis concluded

2021 Year 02 Month 11 Day


Other

Other related information

Because of retirement of collaborative researchers, it would be very difficult to achieve this study. Therefore, this study was stopped.


Management information

Registered date

2017 Year 11 Month 16 Day

Last modified on

2022 Year 05 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034258


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name