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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000046686
Receipt No. R000053215
Scientific Title The effect of Dipeptidyl Peptidase 4 inhibitor on the insulin resistance in the Japanese patients with type 2 diabetes
Date of disclosure of the study information 2022/01/21
Last modified on 2022/01/20

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Basic information
Public title The effect of Dipeptidyl Peptidase 4 inhibitor on the insulin resistance in the Japanese patients with type 2 diabetes
Acronym The effect of Dipeptidyl Peptidase 4 inhibitor on the insulin resistance in the Japanese patients with type 2 diabetes
Scientific Title The effect of Dipeptidyl Peptidase 4 inhibitor on the insulin resistance in the Japanese patients with type 2 diabetes
Scientific Title:Acronym The effect of Dipeptidyl Peptidase 4 inhibitor on the insulin resistance in the Japanese patients with type 2 diabetes
Region
Japan

Condition
Condition Type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effects of DPP4 inhibitor on peripheral insulin resistance by the glucose clamp technique and on postprandial glucose metabolism by the meal tolerance test in Japanese patients with type 2 diabetes mellitus.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of glucose infusion rate during euglycemic-hyperinsulinemic clamp and improvement of HbA1c and postprandial blood glucose.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 DPP4 inihibitor
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 type 2 diabetes mellitus patient.
Key exclusion criteria Type 1 diabetes mellitus, pancreatic disease, liver disease, renal failure, or those taking diabetogenic medications such as corticosteroids
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Tsuyoshi
Middle name
Last name Okura
Organization Tottori University Faculty of Medicine
Division name Endocrinology and Metabolism
Zip code 683-8504
Address 36-1 Nisi-Cho, Yonago
TEL 0859386517
Email ohkura@tottori-u.ac.jp

Public contact
Name of contact person
1st name Tsuyoshi
Middle name
Last name Okura
Organization Tottori University Faculty of Medicine
Division name Endocrinology and Metabolism
Zip code 683-8504
Address 36-1 Nisi-Cho, Yonago
TEL 0859386517
Homepage URL
Email ohkura@tottori-u.ac.jp

Sponsor
Institute Tottori University Faculty of Medicine
Institute
Department

Funding Source
Organization Tottori University Faculty of Medicine
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 Tottori University Faculty of Medicine
Address 36-1 Nisi-Cho, Yonago
Tel 0859386517
Email ohkura@tottori-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
2022 Year 01 Month 21 Day

Related information
URL releasing protocol https://www.jstage.jst.go.jp/article/tonyobyo/59/1/59_59/_pdf/-char/ja
Publication of results Partially published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/tonyobyo/59/1/59_59/_pdf/-char/ja
Number of participants that the trial has enrolled 10
Results improved insulin resistance
Results date posted
2022 Year 01 Month 19 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics type 2 DM
Participant flow outpatients
Adverse events none
Outcome measures GIR
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 01 Month 28 Day
Date of IRB
2013 Year 01 Month 28 Day
Anticipated trial start date
2013 Year 03 Month 23 Day
Last follow-up date
2014 Year 08 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 01 Month 21 Day
Last modified on
2022 Year 01 Month 20 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053215

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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