UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019018 |
|---|---|
| Receipt number | R000021947 |
| Scientific Title | The evaluations of glucose metabolism, bone metabolism, vascular endothelial function and lipid metabolism by the hormone which regulates circadian rhythm in type 2 diabetes. |
| Date of disclosure of the study information | 2015/09/14 |
| Last modified on | 2015/09/15 18:05:52 |
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Basic information
Public title
The evaluations of glucose metabolism, bone metabolism, vascular endothelial function and lipid metabolism by the hormone which regulates circadian rhythm in type 2 diabetes.
Acronym
The evaluations of glucose metabolism, bone metabolism, vascular endothelial function and lipid metabolism by the hormone which regulates circadian rhythm in type 2 diabetes.
Scientific Title
The evaluations of glucose metabolism, bone metabolism, vascular endothelial function and lipid metabolism by the hormone which regulates circadian rhythm in type 2 diabetes.
Scientific Title:Acronym
The evaluations of glucose metabolism, bone metabolism, vascular endothelial function and lipid metabolism by the hormone which regulates circadian rhythm in type 2 diabetes.
Region
| Japan |
Condition
Condition
type 2 diabetes and non diabetes patients
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of glucose metabolism, bone metabolism, vascular endothelial function and lipid metabolism by the hormone which regulates circadian rhythm in type 2 diabetes
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between melatonin and glucose metabolism in type 2 diabetes and non-diabetic patients
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Subjects with FPG <180 mg/dl
(2)Subjects who have not been administered insulin or insulin resistance improving drug four weeks before admission.
(3)Subjects who have never recieved treatment of osteoporosis
(4)Subjects who give consent document about participation in the clinical study
Key exclusion criteria
(1) With diabetic ketoacidosis, diabetic coma and type 1 diabetes
(2) With an abnormality in the endocrine hormone levels
(3)With severe infections
(4)Subjects who have administered melatonin or melatonin receptor agonist
(5)Subjects with cognitive decline (less than 23 points in the MMSE).
(6)Subjects With malignancy within 5 years
(7) Considered as inadequate by the investigator
Target sample size
168
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yosuke Okada |
Organization
University of Occupational and Environmental Health
Division name
First Department of Internal Medicine, School of Medicine
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu
TEL
093-603-1611
y-okada@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kenichi tanaka |
Organization
University of Occupational and Environmental Health
Division name
First Department of Internal Medicine, School of Medicine
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu
TEL
093-603-1611
Homepage URL
kenichi.tanaka0801@gmail.com
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan, First Department of Internal Medicine, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
University of Occupational and Environmental Health, Japan, First Department of Internal Medicine, School of Medicine
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
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
| 2015 | Year | 09 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cross-sectional study
Recruitment of Subject:
from December/2014 to May 2017, patients who meet the inclusion/exclusion criteria
Parameters:6-sulfatoxymelatonin, glucose metabolism, bone metabolism, vascular endothelial function, lipid metabolism, Pittsburgh sleep questionnaire
Management information
Registered date
| 2015 | Year | 09 | Month | 14 | Day |
Last modified on
| 2015 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021947
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
