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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027445
Receipt No. R000031441
Scientific Title Analysis of the metabolic syndrome improvement with the orexin receptor antagonist
Date of disclosure of the study information 2017/06/01
Last modified on 2017/11/20

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

Public contact
1st name of contact person
1st name
Middle name
Last name MITSURU NISHIYAMA
Organization Kochi Medical School, Kochi University
Division name Department of Endocrinology, Metabolism & Nephrology
Zip code
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
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 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
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 Open public recruiting
Date of protocol fixation
2016 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 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 05 Month 22 Day
Last modified on
2017 Year 11 Month 20 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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