UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029169 |
|---|---|
| Receipt number | 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 12:17:13 |
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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
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
taku-koyama@umin.ac.jp
Sponsor or person
Institute
Chiyukai Fukuoka Wajiro 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
Division of cardiovascular medicine, Saga university
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
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±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.
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012442
