UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029999
Receipt No. 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 2017/11/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Masahiro Nishi
Organization Wakayama Medical University
Division name Division of Clinical Nutrition and Metabolism
Zip code
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
Middle name
Last name Shuhei Morita
Organization Wakayama Medical University
Division name The First Department of Medicine
Zip code
Address 811-1 Kimiidera, Wakayama-City, Wakayama prefecture
TEL 073-441-0625
Homepage URL
Email shuhei0528@gmail.com

Sponsor
Institute Wakayama Medical University
Institute
Department

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
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
2017 Year 12 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 11 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 12 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
2017 Year 11 Month 16 Day
Last modified on
2017 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.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


Contact us.