UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027835 |
|---|---|
| Receipt number | R000031871 |
| Scientific Title | Comparison of weight loss effect of diabetes treatment for obese type 2 diabetic patients. |
| Date of disclosure of the study information | 2017/06/26 |
| Last modified on | 2017/06/20 09:01:07 |
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Basic information
Public title
Comparison of weight loss effect of diabetes treatment for obese type 2 diabetic patients.
Acronym
Comparison of weight loss effect of diabetes treatment for obese type 2 diabetic patients.
Scientific Title
Comparison of weight loss effect of diabetes treatment for obese type 2 diabetic patients.
Scientific Title:Acronym
Comparison of weight loss effect of diabetes treatment for obese type 2 diabetic patients.
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By bariatric surgery on obese type 2 diabetic patients, not only weight loss effect but also metabolic improvement effect can be expected. However, bariatric surgery, which is applied for insurance in Japan, is only sleeve gastrectomy. Patients with obesity, which is an indication for surgery, are, in principle, patients with primary obesity between the ages of 18 and 65, and there is no significant weight loss and no improvement in obesity related complications despite medical treatments for more than 6 months.
Until recently, although diabetes treatment have an effect of improving blood glucose, body weight gain accompanying treatment became a problem.
GLP-1 receptor agonist and SGLT2 inhibitor are on the market. I evaluated the effect of GLP-1 receptor agonist and SGLT-2 inhibitor on obese type 2 diabetic patients on the parameters of blood glucose and BMI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c(0M,6M)
Key secondary outcomes
BMI(0M,6M)
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
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The group treated with GLP-1 receptor agonist(Duration:6 months)
Interventions/Control_2
The group treated with SGLT-2 inhibitor(Duration:6 months)
Interventions/Control_3
The group treated with GLP-1 receptor agonist and SGLT-2 inhibitor(Duration:6 months)
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
BMI>=22.0
Key exclusion criteria
Renal dysfunction(eGFR>=30mL/min/1.73m2)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahisa Hasegawa |
Organization
KYORITSU HOSPITAL
Division name
internal medicine
Zip code
Address
16-5, Chuo-cho, Kawanishi-city,Hyogo
TEL
072-758-1131
h.taka517@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahisa Hasegawa |
Organization
KYORITSU HOSPITAL
Division name
internal medicine
Zip code
Address
16-5, Chuo-cho, Kawanishi-city,Hyogo
TEL
072-758-1131
Homepage URL
h.taka517@gmail.com
Sponsor or person
Institute
KYORITSU HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
KYORITSU HOSPITAL
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
協立病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 26 | 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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | 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
| 2017 | Year | 06 | Month | 20 | Day |
Last modified on
| 2017 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031871
