UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of the metabolic syndrome improvement with the orexin receptor antagonist
Acronym	Effect of orexin receptor antagonist on metabolic syndrome
Scientific Title	Analysis of the metabolic syndrome improvement with the orexin receptor antagonist
Scientific Title:Acronym	Effect of orexin receptor antagonist on metabolic syndrome
Region	Japan

Condition
Condition	Metabolic syndrome with insomnia
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The patients of metabolic syndrome (MS) increased in these days. Because high rate of cardiovascular disease are observed in MS, it's important to clarify pathogenesis and therapy of MS. In insomniac patients, it's possible humoral abnormality cause obesity or MS. It's known the neural network of orexin are associated with awakening and appetite. Although it's possible orexin receptor antagonist (suvorexant) improve MS, it's unknown whether suvorexant show these effect. We are going to analyze the effect of suvorexant on MS with insomnia in this study
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We will evaluate whether the patients fill the criteria of MS 6 months after suvorexant treatment. MS criteria is satisfied with abdominal circumference is higher than 85cm in male and 90cm in female, and with higher than two items in follows: (1) Dyslipidemia: triglyceride is higher than 150mg/dl and/or HDL cholesterol is lower than 40mg/dl. (2) Hypertension: systolic blood pressure is higher than 130mmHg and/or diastolic blood pressure is higher than 85mmHg. (3) Impaired glucose tolerance: fasting blood glucose is higher than 110mg/dl.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Orexin receptor antagonist (suvorexant) 20mg
Interventions/Control_2
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	The patients satisfying metabolic syndrome criteria with insomnia
Key exclusion criteria	The patients appeared harmful effect of suvorexant The patients prescribed with CYP3A inhibitory drugs
Target sample size	15

Research contact person
Name of lead principal investigator	1st name MITSURU Middle name Last name NISHIYAMA
Organization	Kochi Medical School, Kochi University
Division name	Department of Endocrinology, Metabolism & Nephrology
Zip code	783-8505
Address	Kohasu, Oko-cho, Nankoku city, Kochi 783-8505, Japan
TEL	088-880-2343
Email	nisiyamm@kochi-u.ac.jp

Public contact
Name of contact person	1st name MITSURU Middle name Last name NISHIYAMA
Organization	Kochi Medical School, Kochi University
Division name	Department of Endocrinology, Metabolism & Nephrology
Zip code	783-8505
Address	Kohasu, Oko-cho, Nankoku city, Kochi 783-8505, Japan
TEL	088-880-2343
Homepage URL
Email	nisiyamm@kochi-u.ac.jp

Sponsor
Institute	Kochi University
Institute
Department

Funding Source
Organization	Kochi University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Osaka Gyomeikan Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee in Kochi University
Address	1-5-2, Akebono-cho, Kochi city
Tel	088-844-0111
Email	rinri21@kochi-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	2017 Year 06 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	0
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	Terminated
Date of protocol fixation	2016 Year 03 Month 01 Day
Date of IRB	2016 Year 03 Month 31 Day
Anticipated trial start date	2016 Year 04 Month 01 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	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 05 Month 22 Day
Last modified on	2020 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031441