UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014621 |
|---|---|
| Receipt number | R000016647 |
| Scientific Title | Effects of Exercise Training and DPP-4 Inhibitors on Cardiovascular Function in Type 2 Diabetic Patients with Myocardial Infarction. |
| Date of disclosure of the study information | 2014/07/24 |
| Last modified on | 2018/05/09 11:16:27 |
* 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
Effects of Exercise Training and DPP-4 Inhibitors on Cardiovascular Function in Type 2 Diabetic Patients with Myocardial Infarction.
Acronym
Exercise and DPP-4 Inhibitors in Type 2 Diabetics with Myocardial Infarction
Scientific Title
Effects of Exercise Training and DPP-4 Inhibitors on Cardiovascular Function in Type 2 Diabetic Patients with Myocardial Infarction.
Scientific Title:Acronym
Exercise and DPP-4 Inhibitors in Type 2 Diabetics with Myocardial Infarction
Region
| Japan |
Condition
Condition
Type 2 diabetic patients with myocardial infraction
Classification by specialty
| Cardiology | Laboratory medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of exercise training and DPP-4 inhibitors on cardiovascular function and exercise capacity in type 2 diabetic patients with acute myocardial infraction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise capacity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
Exercsei tarining and DPP-4 inhibitors(linagliptin)
Interventions/Control_2
Exercse training alone
Interventions/Control_3
DPP-4 inhibitors (linagliptin) alone
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 diabetic patients undergoing primary percutaneous coronary intervention for myocardial infarction.
Key exclusion criteria
Type 1 diabetics, residual coronary stenosis, severe valvular disease, renal failure, NYHA class 4 heart failure, atrial fibrillation, hypertrophic cardiomyopathy, therapies with insulin, glinides, previous cardiac rehabilitation, and pacemakers.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Fujimoto |
Organization
Mie University Graduate School of Medicine
Division name
Department of Molecular and Laboratory Medicine
Zip code
Address
2-174 Edobashi, Tsu, Mie
TEL
059-231-5161
naokifujimo@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoto Kumagai |
Organization
Mie University Graduate School of Medicine
Division name
Department of Cardiology and Nephrology
Zip code
Address
2-174 Edobashi, Tsu, Mie
TEL
059-231-5015
Homepage URL
kumagain@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Cardiology and Nephrology, Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Molecular and Laboratory Medicine, Mie University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Department of Cardiology and Nephrology, Mie University Graduate School of Medicine
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
三重大学病院（三重県）、永井病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 24 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 24 | 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 | 23 | Day |
Last modified on
| 2018 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016647
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
