UMIN-CTR Clinical Trial

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
Email	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/
Email	ohta@oita-u.ac.jp

Sponsor
Institute	Oita University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042370