UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034407 |
|---|---|
| Receipt number | R000039237 |
| Scientific Title | Predictive marker of good responder after laparoscopic sleeve gastrectomy in obese patients with type 2 diabetes |
| Date of disclosure of the study information | 2018/10/08 |
| Last modified on | 2021/04/12 20:13:53 |
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Basic information
Public title
Predictive marker of good responder after laparoscopic sleeve gastrectomy in obese patients with type 2 diabetes
Acronym
Glucose response after LSG
Scientific Title
Predictive marker of good responder after laparoscopic sleeve gastrectomy in obese patients with type 2 diabetes
Scientific Title:Acronym
Glucose response after LSG
Region
| Japan |
Condition
Condition
Obese patients with type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the changes in glucose tolerance and metabolic disorders between before and after laparoscopic sleeve gastrectomy (LSG) in obese type 2 diabetes.
Basic objectives2
Others
Basic objectives -Others
We also seek the predictive marker of good responder among patients undergone LSG by using the result of OGTT before LSG.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete remission of type 2 diabetes
Key secondary outcomes
Weight loss after LSG (kg)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Obese patients with type 2 diabetes who are going to undergo laparoscopic sleeve gastrectomy. Patients need to be >35 kg/m2 of their body mass index.
Key exclusion criteria
Patients who have cardiovascular disease, respitratory disease, inflammatory gastrointestinal disease, alcohol abuse, psychological hyperpahagia.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Horie |
Organization
Nagasaki University
Division name
Department of Endocrinology and Metabolism
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197200
holy197741@me.com
Public contact
Name of contact person
| 1st name | Ichiro |
| Middle name | |
| Last name | Horie |
Organization
Nagasaki University
Division name
Department of Endocrinology and Metabolism
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197200
Homepage URL
holy197741@me.com
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
Nagasaki University Hospital Clinical Study Review Board
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7200
holy197741@me.com
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
| 2018 | Year | 10 | Month | 08 | 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
| Delay expected |
Results Delay Reason
We are now collecting data.
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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
On going
Management information
Registered date
| 2018 | Year | 10 | Month | 08 | Day |
Last modified on
| 2021 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039237
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| Registered date | File name |
| Research case data | |
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