UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024411 |
|---|---|
| Receipt number | R000023299 |
| Scientific Title | Research of the blood levels of hepatokines during meals and an oral glucose tolerance test |
| Date of disclosure of the study information | 2016/10/14 |
| Last modified on | 2021/04/22 09:04:06 |
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Basic information
Public title
Research of the blood levels of hepatokines during meals and an oral glucose tolerance test
Acronym
Research of the blood levels of hepatokines during meals and OGTT
Scientific Title
Research of the blood levels of hepatokines during meals and an oral glucose tolerance test
Scientific Title:Acronym
Research of the blood levels of hepatokines during meals and OGTT
Region
| Japan |
Condition
Condition
Impaired glucose tolerance
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the blood levels of selenoprotein P , LECT2, glucose, insulin and other metabolic biomarkers during meal or 75g oral glucose tolerance test. Subjects have type 2 diabetes, impaired glucose tolerance or other metabolic diseases.
Basic objectives2
Others
Basic objectives -Others
To analyze the correlation of the circadian rhythm of hepatokines and known biomarkers
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of blood levels of selenoprotein P and LECT2 during meal and an oral glucose test
Key secondary outcomes
Correlation of hepatokines and biomarkers (blood glucose, IRI, GLP-1, GIP, ACTH, cortisole, GH) or basic profiles of the subjects
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with type 2 diabetes or impaired glucose tolerance
2) Patients suspected impaired glucose tolerance who fits these conditons
a. BMI >= 25
b. fasting blood glucose levels >= 100mg/dL
c. blood glucose levels at any time >= 140mg/dL
d. HbA1c >= 6.0%
e. Patients have dyslipidemia or fatty liver
Key exclusion criteria
1) Pregnant
2) Steroid pulse treatment
3) Current malignancy
4) Anemia under Hb 9g/dL
5) Liver chirrhosis (Child-Pugh score C)
6) Over diabetes over HbA1c 9%(NGSP) will not be included in oral glucose tests
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takamura Toshinari |
Organization
Kanazawa University Hospital
Division name
Endocrinology and Metabolism 1
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2233
ttakamura@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takamura Toshinari |
Organization
Kanazawa University Hospital
Division name
Endocrinology and Metabolism 1
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2233
Homepage URL
ttakamura@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University Hospital, Endocrinology and Metabolism 1
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
| 2016 | Year | 10 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 31 | Day |
Other
Other related information
N/A
Management information
Registered date
| 2016 | Year | 10 | Month | 14 | Day |
Last modified on
| 2021 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023299
| 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 |
