UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013030 |
|---|---|
| Receipt number | R000014476 |
| Scientific Title | Study of metabolism-related markers of bariatric surgery before and after in obese patients with type 2 diabetes |
| Date of disclosure of the study information | 2014/01/31 |
| Last modified on | 2015/09/26 01:56:12 |
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Basic information
Public title
Study of metabolism-related markers of bariatric surgery before and after in obese patients with type 2 diabetes
Acronym
Study of metabolism-related markers of bariatric surgery before and after in obese patients with type 2 diabetes
Scientific Title
Study of metabolism-related markers of bariatric surgery before and after in obese patients with type 2 diabetes
Scientific Title:Acronym
Study of metabolism-related markers of bariatric surgery before and after in obese patients with type 2 diabetes
Region
| Japan |
Condition
Condition
obese patients with type 2 diabetes
Classification by specialty
| Medicine in general | Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
assessment of blood glucose control , insulin sensitivity and secretion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)HbA1c
2)body weight
3)matsuda index
4)insulinogenic index
Key secondary outcomes
1)AST,ALT
2)T-chol,TG,HDL-chol,LDL-chol
3)active-ghrelin,desacyl-ghrelin,leptin,adiponectin
4)urinalysis
Base
Study type
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
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
1)standard therapy(diet,exercise,and oral hypoglycemic agent)
Interventions/Control_2
2)bariatric surgery
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
obese patients body mass index over 32 with type 2 diabetes
Key exclusion criteria
1.Individuals recieved insulin therapy
2.Individuals recieved steroid therapy ,immunosuppressant , Azole antifungal agents.
3.Individuals judged to have nephrotic syndrome.
4.cerebral vascular disorder and acute coronary artery disease within 6 months
5.Individuals judged to have severe heart failure , severe irregular Heart Beat.Individuals judged to have myocardial ischemia and recieve PCI.
6.Pregnant women, or women with intending
to become pregnant, and lactating women.
7.Individuals judged by the doctor to be
unsuitable.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Hanafusa |
Organization
Osaka Medical College
Division name
Department of Internal Medicine (1)
Zip code
Address
2-7 Daigaku-machi, Takatsuki City, Osaka
TEL
072-683-1221
hanafusa@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisashi Imbe |
Organization
Osaka Medical College
Division name
Department of Internal Medicine (1)
Zip code
Address
2-7 Daigaku-machi, Takatsuki City, Osaka
TEL
072-683-1221
Homepage URL
in1297@poh.osaka-med.ac.jp
Sponsor or person
Institute
Department of Internal Medicine(1),Osaka
Medical College
Institute
Department
Personal name
Funding Source
Organization
Department of Internal Medicine(1),Osaka
Medical College
Organization
Division
Category of Funding Organization
Self funding
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 | 01 | Month | 31 | 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
Impaired glucose tolerance was improved.
The 34th Annual Meeting of Japan Society for the Study of Obesity.
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
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 03 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 03 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 03 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 31 | Day |
Last modified on
| 2015 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014476
| 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 |
