UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037180 |
|---|---|
| Receipt number | R000042370 |
| Scientific Title | Comparison between ABCD and IMS scores in prediction of long-term T2DM remission after metabolic surgery in East Asian obese patients |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2022/06/29 12:48:25 |
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Basic information
Public title
Comparison between ABCD and IMS scores in prediction of long-term T2DM remission after metabolic surgery in East Asian obese patients
Acronym
Comparison between scoring systems in prediction of T2DM remission after metabolic surgery in East Asian obese patients
Scientific Title
Comparison between ABCD and IMS scores in prediction of long-term T2DM remission after metabolic surgery in East Asian obese patients
Scientific Title:Acronym
Comparison between scoring systems in prediction of T2DM remission after metabolic surgery in East Asian obese patients
Region
| Japan | Asia(except Japan) |
Condition
Condition
Obesity with type 2 diabetes
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare ABCD score with Individualized Metabolic Surgery (IMS) score in terms of prediction of T2DM remission in East Asian obese patients 3 and 5 years after metabolic surgery, to evaluate who were good candidates for sleeve gastrectomy (SG), and to adjust IMS points to East Asian patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Which scoring system is better in prediction of T2DM remission in East Asian obese patients 3 and 5 years after metabolic surgery?
Key secondary outcomes
Who were good candidates for sleeve gastrectomy in East Asian countries?
What is the better borderline point between mild and moderate stages in IMS score in East Asian countries?
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Obese diabetic patients 3 years or more after sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), resectional RYGB, mini-gastric bypass (one anastomosis gastric bypass), and SG with duodenojejunal bypass (SG-DJB) as the primary operation
Key exclusion criteria
Patients who are not diagnosed as T2DM before operation
Patients who have no data of preoperative C-peptide
Patients who experienced severe complications such as leakage just after the first operation
Patients who received revision surgery within 3 years after the first operation
Patients who received pregnancy within 3 years after the first operation
Patients who have lack of 3 years data (between 3-4 years)
Patients who received other operations than SG, RYGB, resectional RYGB, mini-gastric bypass, and SG-DJB
Patients who received open metabolic surgery (not laparoscopic)
When patients experienced revision surgery or pregnancy between 4-5 years, 5 years data are only excluded.
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Ohta |
Organization
Oita University
Division name
Global Oita Medical Advanced Research Center for Health
Zip code
8795593
Address
1-1 Idaigaoka, Hasama-machi, Yufu,, Oita
TEL
81975865843
ohta@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Ohta |
Organization
Oita University
Division name
Global Oita Medical Advanced Research Center for Health
Zip code
8795593
Address
1-1 Idaigaoka, Hasama-machi, Yufu,, Oita
TEL
81975865843
Homepage URL
http://www.surgery1.med.oita-u.ac.jp/patient/guide06/
ohta@oita-u.ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Funding Source
Organization
Oita University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
General Affairs Division, Oita University Faculty of Medicine
Address
1-1 Idaigaoka, Hasama-machi, Yufu,, Oita
Tel
+81-97^586-5012
rinrikenkyu@oita-u.ac.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
| 2019 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.surgery1.med.oita-u.ac.jp/patient/guide06/
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/content/pdf/10.1007/s11695-020-05151-6.pdf
Number of participants that the trial has enrolled
24
Results
he two scoring systems were significantly well correlated. The IMS scoring system showed significant differences in T2DM remission rates between the procedures in the moderate stage, but the ABCD score showed no significant differences in each category. The discrimination power of the IMS score was comparable to that of the ABCD score at both 3 and 5 years. The revised IMS scoring system showed that SG-DJB had significantly higher T2DM remission rates in the moderate stage at 5 years than RYGB or SG.
Results date posted
| 2022 | Year | 06 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
24 bariatric/metabolic surgeons from Japan, Korea and China
Participant flow
The number was planned to be 29, but it was reduced to 24.
Adverse events
No adverse events
Outcome measures
Comparison of 2 scoring systems and correction of thresholds for mild and moderate stages of IMS scores
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Metabolic surgery
Management information
Registered date
| 2019 | Year | 06 | Month | 26 | Day |
Last modified on
| 2022 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042370
