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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042370


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name