UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012418 |
|---|---|
| Receipt number | R000014535 |
| Scientific Title | The Impact on Surrogate Markers by therapeutic changes IN lifeSTyle rElAted Diseases (ISM-Tx INSTEAD) |
| Date of disclosure of the study information | 2013/11/27 |
| Last modified on | 2019/06/02 15:36:18 |
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Basic information
Public title
The Impact on Surrogate Markers by therapeutic changes IN lifeSTyle rElAted Diseases (ISM-Tx INSTEAD)
Acronym
ISM-Tx INSTEAD
Scientific Title
The Impact on Surrogate Markers by therapeutic changes IN lifeSTyle rElAted Diseases (ISM-Tx INSTEAD)
Scientific Title:Acronym
ISM-Tx INSTEAD
Region
| Japan |
Condition
Condition
Diabetes Mellitus
Hypertention
Dyslipidemia
Smoking
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of therapy or therapeutic change on surrogate markers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of surrogate markers in each group
Key secondary outcomes
Change of disease markers in each group
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
anti-diabetic agent
Interventions/Control_2
anti-hypertensive agent
Interventions/Control_3
lipid therapeutic agent
Interventions/Control_4
antiplatelet agent
Interventions/Control_5
smoking-cessation aid
Interventions/Control_6
admission
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with diabetes
2)Patients needed to be intervened
3)Patients without any therapeutic change for 4 weeks before intervention
4)Patients agree to entry to the study
Key exclusion criteria
Patients with:
1)anaphylaxis to the intended therapy
2)contraindication to the intended therapy
3)severe ketoacidosis, diabetic coma and pre-coma
4)severe renal dysfunction CCR<=30ml/min, SCr >2.5mg/dl(male),>2.0mg/dl(female)
5)severe infection, pre- and post-operation, severe injury
6)pregnancy, lactation, and
7)expected cessation of intended therapy or expected addition of other therapy
8)other contraindication
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Akifumi |
| Middle name | |
| Last name | Kushiyama |
Organization
The Institute for Adult Diseases, Asahi Life Foundation
Division name
Diabetes and Metabolism
Zip code
1030002
Address
2-2-6, Nihonbashi Bakurocho, Chuo-ku, Tokyo
TEL
03-3639-5501
kusiyaa-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Akifumi |
| Middle name | |
| Last name | Kushiyama |
Organization
The Institute for Adult Diseases, Asahi Life Foundation
Division name
Diabetes and Metabolism
Zip code
1030002
Address
2-2-6, Nihonbashi Bakurocho, Chuo-ku, Tokyo, Japan
TEL
03-3639-5501
Homepage URL
http://www.asahi-life.or.jp
kusiyaa-tky@umin.ac.jp
Sponsor or person
Institute
The Institute for Adult Diseases, Asahi Life Foundation
Institute
Department
Personal name
Funding Source
Organization
The Institute for Adult Diseases, Asahi Life Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institute for Adult Diseases, Asahi Life Foundation
Address
NihonbashiBakurocho2-2-6
Tel
+81336395501
a-kushiyama@asahi-life.or.jp
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
| 2013 | Year | 11 | Month | 27 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
182
Results
N/A
Results date posted
| 2019 | Year | 06 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
N/A
Participant flow
N/A
Adverse events
N/A
Outcome measures
N/A
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 16 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 10 | Month | 15 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 27 | Day |
Last modified on
| 2019 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014535
| Research Plan | |
|---|---|
| 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 |
