UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013191 |
|---|---|
| Receipt number | R000015384 |
| Scientific Title | Influence of linagliptin (DPP-4 inhibitor) on heart autonomic nervous system, heart function and visceral fat area |
| Date of disclosure of the study information | 2014/02/20 |
| Last modified on | 2016/09/19 15:14:53 |
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Basic information
Public title
Influence of linagliptin (DPP-4 inhibitor) on heart autonomic nervous system, heart function and visceral fat area
Acronym
Influence of linagliptin (DPP-4 inhibitor) on heart autonomic nervous system, heart function and visceral fat area
Scientific Title
Influence of linagliptin (DPP-4 inhibitor) on heart autonomic nervous system, heart function and visceral fat area
Scientific Title:Acronym
Influence of linagliptin (DPP-4 inhibitor) on heart autonomic nervous system, heart function and visceral fat area
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus.
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess heart autonomic nervous system, ECG variability and QTc variability using the heart rate variability and visceral fat variability of linagliptin for type 2 diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of ECG (Heart rate variability, QT variability) and visceral fat area and subcutaneous fat area by BIA from baseline (Visit 0) to 12 and 24 weeks.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
DPP-4 inhibitor (linagliptin)
Interventions/Control_2
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Type 2 diabetic patients (HbA1c(NGSP value),higher than 6.5% but lower than 9.0%)
2) Patients who can begin treatment linagliptin this study, but patients who had taken other DPP-4 inhibitor. (Not washout period)
3) Patients who are stably treating with lipid-lowering drugs or Anti-hypertension drugs
4) Age,20-80(Male and female)
5) Written informed consent are taken for the enrollment
Key exclusion criteria
1)Type 2 diabetic patients (HbA1c(NGSP value),higher than 6.5% but lower than 9.0%)
2) Patients who can begin treatment linagliptin this study, but patients who had taken other DPP-4 inhibitor. (Not washout period)
3) Patients who are stably treating with lipid-lowering drugs or Anti-hypertension drugs
4) Age,20-80(Male and female)
5) Written informed consent are taken for the enrollment
1) Patients who are Type I or Secondary diabetic mellitus
2) Patients who are treating with GLP-1 agonist or Thiazolidinedione at the time of study initiation
3) Patients who are severe infectious disease, perioperative, and severe trauma
4)Patients with myocardial infarction, angina pectoris, cerebral stroke, or cerebral infarction
5) Patients with moderate or severer heart failure (NYHA/New York Heart Association stage 3 or severer)
6) Patients who are pregnant, lactating, and possibly pregnant women and those planning to become pregnant
7) Patients with a history of hypersensitivity to investigational drugs
8) Patients with cancer
9) Patients who receive steroid therapy with inflammatory affection
10) Patients whom doctor judges as ineligible to this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Izuru Masuda |
Organization
Takeda Hospital
Division name
Medical Examination Center
Zip code
Address
3F, Nihonseimei Kyoto Santetsu Bldg 608 Higashi-Shiokoji-cho, Shimogyoku, Kyoto, Japan
TEL
075-365-0825
imasuda@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Izuru Masuda |
Organization
Takeda Hospital
Division name
Medical Examination Center
Zip code
Address
3F, Nihonseimei Kyoto Santetsu Bldg 608 Higashi-Shiokoji-cho, Shimogyoku, Kyoto, Japan
TEL
075-365-0825
Homepage URL
imasuda@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Takeda Hospital Medical Examination Center
Institute
Department
Personal name
Funding Source
Organization
Japan Vascular Disease Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 11 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 20 | 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 | 02 | Month | 18 | Day |
Last modified on
| 2016 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015384
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
