UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of antidiabetic drug on endothelial function
Title of the study (Brief title)	EFFORT
Region	Japan

Condition
Condition	Untreated type 2 diabetic patients with ischemic heart disease
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of DPP4 inhibitor and alpha glucosidase inhibitor on vascular endothelial function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes of RHI(Reactive hyperemia index)
Key secondary outcomes	blood glucose, serum insulin level, HbA1c(NGSP), LDL, HDL, Triglyceride, total cholesterol, urine albumin/creatinine ratio, MDA-LDL, hs-CRP, IL-8, MCP-1, periostin, RAGE, HMW adiponectin, NT-pro BNP, active GLP1

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Linagliptin 5mg once a day for 3 months
Interventions/Control_2	Voglibose 0.3mg three times a day for 3 months
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	Patients 1) with ischemic heart disease (old myocardial infarction, stable angina pectoris, silent myocardial ischemia, history of percutaneous transluminal coronary angioplasty, history of coronary artery bypass grafting) 2) with untreated diabetic melitus and HbA1c (NGSP) less than or equal to 6.4% 3) with unchanged medication during latest 1 month 4) aged 20 years old or older
Key exclusion criteria	1. Patients with liver disease (ALT or AST level is over 100IU/L, total Bil level is over 2.5mg/dl). 2. Patients with congenital heart disease. 3. Patients with highly advanced cardiac dysfunction. 4. Patients with endocrine disease. 5. Patients with malignancy or inflammatory disease. 6. Patinets with highly advanced respiratory disease (containing pulmonary arterial pulmonary hypertension. 7. Patients with cranial nerve disease or locomotor apparatus disease, and severely compromised daily life. 8. Patients with severe hypertension. 9. Patients administrated steroid or immune suppressor. 10. Patients with type1 DM or type2 DM and HbA1c (NGSP) 6.5% or more. 11. Patients during pregnancy or with possibility of pregnancy. 12. Patients administrated catecholamine. 13. Patients with symptomatic hypotension. 14. Patients with significant LVOT obstruction (Hypertrophic obstructive cardiomyopathy or aortic stenosis). 15. Patients without written consent. 16. Patients recognized inadequate by primary doctor.
Target sample size	40

Research contact person
Name of lead principal investigator	Koichi Node
Organization	Saga university
Division name	Department of cardiovascular medicine
Address	5-1-1 Nabeshima Saga-city
TEL	0952(34)2364
Email	node@cc.saga-u.ac.jp

Public contact
Name of contact person	Taku Koyama
Organization	Chiyukai Fukuoka Wajiro hospital
Division name	Cardiovascular medicine
Address	2-2-75 Wajirogaoka Higashi-ku Fukuoka-city
TEL	092(608)0001
Homepage URL
Email	taku-koyama@umin.ac.jp

Sponsor
Institute	Chiyukai Fukuoka Wajiro hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Division of cardiovascular medicine, Saga university
Name of secondary funｄer(s)

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	池友会　福岡和白病院

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 16 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 06 Month 10 Day
Anticipated trial start date	2013 Year 08 Month 31 Day
Last follow-up date	2017 Year 09 Month 20 Day
Date of closure to data entry	2017 Year 09 Month 20 Day
Date trial data considered complete	2017 Year 09 Month 30 Day
Date analysis concluded	2018 Year 03 Month 17 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	The RH-PAT and laboratory parameters, including 75 g oral glucose tolerance test, were measured at baseline and 3 months. Linagliptin reduced serum levels of glucose and insulin at 2 hours, and increased levels of active glucagon-like peptide-1 and high-molecular-weight adiponectin. Age-, sex-, and baseline-adjusted changes in logarithmic RH-PAT index (LnRHI) after 3 months were significant between groups (linagliptin, 0.135±0.097; voglibose, -0.124±0.091; P=0.047). In the linagliptin group, change in LnRHI was positively correlated with change in high-density lipoprotein cholesterol and negatively correlated with changes in both urine albumin-to-creatinine ratio and high-sensitivity C-reactive protein.
Other related information

Management information
Registered date	2017 Year 09 Month 16 Day
Last modified on	2018 Year 03 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012442