UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Exercise Training and DPP-4 Inhibitors on Cardiovascular Function in Type 2 Diabetic Patients with Myocardial Infarction.
Title of the study (Brief title)	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	Naoki Fujimoto
Organization	Mie University Graduate School of Medicine
Division name	Department of Molecular and Laboratory Medicine
Address	2-174 Edobashi, Tsu, Mie
TEL	059-231-5161
Email	naokifujimo@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Naoto Kumagai
Organization	Mie University Graduate School of Medicine
Division name	Department of Cardiology and Nephrology
Address	2-174 Edobashi, Tsu, Mie
TEL	059-231-5015
Homepage URL
Email	kumagain@clin.medic.mie-u.ac.jp

Sponsor
Institute	Department of Cardiology and Nephrology, Mie University Graduate School of Medicine
Institute
Department

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

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016647