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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024411
Receipt No. 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 2018/10/17

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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
Email 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
Email ttakamura@m-kanazawa.jp

Sponsor
Institute Kanazawa University Hospital
Institute
Department

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
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
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 No longer recruiting
Date of protocol fixation
2014 Year 09 Month 17 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 17 Day
Last follow-up date
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
2018 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023299

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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