UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032014 |
|---|---|
| Receipt number | R000036534 |
| Scientific Title | To identify the presence of type 2 diabetes patients with elevated insulin clearance and clarify there clinical characteristics. |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2021/10/13 09:41:36 |
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Basic information
Public title
To identify the presence of type 2 diabetes patients with elevated insulin clearance and clarify there clinical characteristics.
determine factors that affect on blood insulin concentrations at steady state in hyperinsulinemic-euglycemic clamp test (insulin clearance).
Acronym
Identification of the presence of type 2 diabetes patients with elevated insulin clearance
Scientific Title
To identify the presence of type 2 diabetes patients with elevated insulin clearance and clarify there clinical characteristics.
Scientific Title:Acronym
Identification of the presence of type 2 diabetes patients with elevated insulin clearance
Region
| Japan |
Condition
Condition
Untreated type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify patients with elevated insulin clearance assessed by hyperinsulinemic-euglycemic clamp test.
Basic objectives2
Others
Basic objectives -Others
To clarify there clinical characteristics.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To identify patients with elevated insulin clearance assessed by hyperinsulinemic-euglycemic clamp test.
Key secondary outcomes
To clarify there clinical characteristics.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
newly diagnosed and drug-treatment naive patient with type 2 diabetes mellitus
Key exclusion criteria
ketoacidosis, pregnancy, cancer, thyroid disease, adrenal tumor, renal failure, active infection, inflammatory disease, autoimmune disease, liver cirrhosis, Viral hepatitis, dementia, schizophrenia, and those who did not accept to have hyperinsulinemic-euglycemic clamp examination.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Kurinami |
Organization
Jinnouchi Hospital
Division name
Diabetes Care Center
Zip code
862-0976
Address
6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
TEL
096-363-0011
kurinami@jinnouchi.or.jp
Public contact
Name of contact person
| 1st name | Noboru |
| Middle name | |
| Last name | Kurinami |
Organization
Jinnouchi Hospital
Division name
Diabetes Care Center
Zip code
862-0976
Address
6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
TEL
096-363-0011
Homepage URL
kurinami@jinnouchi.or.jp
Sponsor or person
Institute
Jinnouchi Hospital
Institute
Department
Personal name
Funding Source
Organization
Jinnouchi Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jinnouchi Hospital
Address
6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
Tel
096-363-0011
hisyo@jinnouchi.or.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
陣内病院（熊本）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | 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
101
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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 13 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 13 | Day |
Date analysis concluded
| 2021 | Year | 10 | Month | 13 | Day |
Other
Other related information
Elevated insulin clearance evaluated by metabolic clearance rate of insulin (MCRI) in hyper insulinemic-euglicemic clamp test.
Management information
Registered date
| 2018 | Year | 03 | Month | 30 | Day |
Last modified on
| 2021 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036534
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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