UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014725 |
|---|---|
| Receipt number | 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 | 2020/08/04 09:50:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
m980287@gmail.com
Sponsor or person
Institute
Division of diabetes, Mitsui Memorial Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 01 | Day |
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
| 2020 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017120
