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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014725
Receipt No. R000017120
Scientific Title Investigation of the effect of the incretin on cardiac function in patients with type 2 diabetes
Date of disclosure of the study information 2014/07/31
Last modified on 2019/02/07

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Basic information
Public title Investigation of the effect of the incretin on cardiac function in patients with type 2 diabetes
Acronym Incretin and cardiac function
Scientific Title Investigation of the effect of the incretin on cardiac function in patients with type 2 diabetes
Scientific Title:Acronym Incretin and cardiac function
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of incretin on cardiac function in patients with type 2 diabetes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Change in cardiac function by echocardiography (including speckle tracking)
Key secondary outcomes 1) All cause death,
2)Cardiovascular events (composite of cardiovascular death, non-fatal myocardial infarction, unstable angina pectoris, non-fatal ischemic stroke, hospitalization for heart failure, coronary revascularization, or hospitalization for peripheral artery disease),

3) Change in fasting glucose, HbA1c, body weight, insluin resistance and secretion, BNP, Hs-CRP, lipids, PUFAs, UACA, CTR, ABI, cartid echography, and ECG.

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 inhibitor treatment group
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 Type 2 diabetes
Key exclusion criteria 1) Allergy of Incretin related drug
2) Patients who receive DPP4 inhibitors or GLP-1 before starting study
3) Pregnant, lactating, possibly pregnant or planning to become pregnant women
4) Renal, hepatic, cardiovascular, thyroid, or hematological disease.
5) Malignant tumor
6) Patients considered as inadequate by the principal investigator
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoru Kishi
Organization Mitsui Memorial Hospital
Division name Division of diabetes
Zip code
Address 1 Kanda Izumicho, Chiyoda-ku, Tokyo
TEL 03-3862-9111
Email skishi@mitsuihosp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Kishi
Organization Mitsui Memorial Hospital
Division name Division of diabetes
Zip code
Address 1 Kanda Izumicho, Chiyoda-ku, Tokyo
TEL 03-3862-9111
Homepage URL
Email m980287@gmail.com

Sponsor
Institute Division of diabetes, Mitsui Memorial Hospital
Institute
Department

Funding Source
Organization None
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
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 社会福祉法人三井記念病院(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 31 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 07 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 31 Day
Last modified on
2019 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017120

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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