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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000029169
Receipt No. R000012442
Scientific Title Effect of antidiabetic drug on endothelial function
Date of disclosure of the study information 2017/09/16
Last modified on 2018/03/18

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Basic information
Public title Effect of antidiabetic drug on endothelial function
Acronym EFFORT
Scientific Title Effect of antidiabetic drug on endothelial function
Scientific Title:Acronym 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
1st name
Middle name
Last name Koichi Node
Organization Saga university
Division name Department of cardiovascular medicine
Zip code
Address 5-1-1 Nabeshima Saga-city
TEL 0952(34)2364
Email node@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taku Koyama
Organization Chiyukai Fukuoka Wajiro hospital
Division name Cardiovascular medicine
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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&plusmn;0.097; voglibose, -0.124&plusmn;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.
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 Main results already published
Date of protocol fixation
2013 Year 06 Month 10 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000012442

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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