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 | 2025/11/17 16:12:41 |
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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 | Yosuke |
| Middle name | |
| Last name | Okada |
Organization
University of Occupational and Environmental Health, Japan
Division name
First Department of Internal Medicine, School of Medicine
Zip code
807-8555
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 | kenichi |
| Middle name | |
| Last name | tanaka |
Organization
University of Occupational and Environmental Health, Japan
Division name
First Department of Internal Medicine, School of Medicine
Zip code
807-8555
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
University of Occupational and Environmental Health, Japan,
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitaksyushu-shi, Fukuoka 1-1 Iseigaoka, Yahatanishi-ku, Kitaksyushu-shi, Fukuoka 1-1 Iseigaoka, Yahatanishi-ku, Kitaksyushu-shi, Fukuoka
Tel
0936031611
sunday@pub.uoeh-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
| 2015 | Year | 09 | Month | 14 | Day |
Related information
URL releasing protocol
Not available
Publication of results
Published
Result
URL related to results and publications
Not available
Number of participants that the trial has enrolled
194
Results
The Ln 6-SMT was significantly lower in T2DM compared with non-diabetes. Multivariate linear regression analysis identified duration of diabetes, smoking status, urinary albumin-to-creatinine ratio, retinopathy and coronary heart disease as factors that could influence Ln 6-SMT levels in T2DM. Ln 6-SMT was associated with decreased odds of diabetic retinopathy and coronary heart disease, even after adjustment for various confounding factors.
Results date posted
| 2025 | Year | 11 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Approximately 80% of the patients without diabetes were admitted to our hospital for further assessment of thyroid tumors. The clinical characteristics of the study patients are shown in Table 1. Compared with the patients without diabetes, those with type 2 diabetes had significantly higher body mass index, were more likely to be hypertensive and current smokers, have dyslipidemia, with significantly lower high-density lipoprotein levels. For the diabetes patients, the mean duration of diabetes was 8.3 years; HbA1c levels were 9.3%, and the homeostasis model assessment for insulin resistance value was 3.5. Their blood glucose levels were poorly controlled, and insulin resistance was common. In addition, the Ln 6-SMT levels were significantly lower among the patients with diabetics than the patients without diabetes.
Participant flow
Of the patients with and those without type 2 diabetes aged between 20 and 80 years who were admitted to the Hospital of the University of Occupational and Environmental Health, Kitakyushu, Japan, between September 2014 and December 2018, we retrieved the medical records of those patients who underwent testing for urinary 6-sulfatoxymelatonin levels. The patients without diabetes included in the analysis were adjusted for age and sex to those of the diabetes group. The following exclusion criteria were applied: patients with type 1 diabetes mellitus, patients with severe infection or serious trauma, patients who were found to have abnormal endocrine hormone levels (excluding those with hormone levels within the normal ranges corrected by treatment), patients with renal dysfunction (estimated glomerular filtration rate [eGFR] of <30 mL/min/1.73 m2), patients receiving oral melatonin or MTNR1b agonists, patients with cognitive decline (Mini-Mental State Examination score 23 or lower) and patients who were known to have malignant tumors within the previous 5 years.
Adverse events
none
Outcome measures
Association between urinary 6-sulfatoxymelatonin levels and diabetic vascular complications/arteriosclerosis in patients with type 2 diabetes
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 09 | Month | 30 | Day |
Other
Other related information
cross-sectional study
Recruitment of Subject:
from December/2014 to December 2018, 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
| 2025 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021947
