UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027445 |
|---|---|
| Receipt number | 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 | 2020/11/25 08:27:19 |
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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
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
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
nisiyamm@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031441
