NCT06254339

Brief Summary

Metabolic bariatric surgery (MBS) has demonstrated its efficacy in achieving sustainable weight loss and alleviating associated comorbidities. The primary objective of our investigation is to assess the long-term impact and sustainability of weight loss, the remission of T2D as well as risk prediction of cardiovascular events following MBS concerning one-anastomosis gastric bypass (OAGB) and duodenojejunal bypass with sleeve gastrectomy (DJB-SG).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
830

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

7 years

First QC Date

January 24, 2024

Last Update Submit

February 9, 2024

Conditions

Obesity

Keywords

One-anastomosis gastric bypassDuodenal-jejunal bypass with sleeve gastrectomyMajor adverse cardiovascular eventsType 2 diabetes mellitusObesityComorbidities

Outcome Measures

Primary Outcomes (4)

  • Body Mass Index (BMI)

    Weight reduction

    3 years

  • Diabetes

    HbA1c change

    3 years

  • Hypertension

    Blood pressure (SBP/BP change)

    3 years

  • Dyslipidemia

    TG, T-CHO, LDL, HDL change

    3 years

Secondary Outcomes (2)

  • Taiwan MACE risk prediction model

    10 years

  • The China-PAR project model

    10 years

Study Arms (2)

OAGB cohort

Application of One-anastomosis gastric bypass (OAGB) procedure stated in IFSO/ASMBS.

Procedure: OAGB

DJB-SG cohort

Application of Duodenojejunal bypass with sleeve gastrectomy (DJB-SG)) procedure stated in IFSO/ASMBS.

Procedure: DJB-SG

Interventions

OAGBPROCEDURE

using OAGB procedure as metabolic bariatric surgery

OAGB cohort
DJB-SGPROCEDURE

using DJB-SG procedure as metabolic bariatric surgery

DJB-SG cohort

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Taiwanese adult patients, whose age are between 20 and 65 years old, with obesity and/or cormobidities and metabolic disorders, such as type 2 diabetes mellitus, hypertension, dyslipidemia, obstructive sleep apnea, etc.

You may qualify if:

  • Patients whose BMI≧37.5 kg/m2 or patients whose BMI≧32.5 kg/m2 and have concurrent high-risk comorbidities, such as hypertension, obstructive sleep apnea, HbA1c≧7.5% after anti-diabetic medication treatment, etc;
  • The patients have been treated with lifestyle intervention, including increase in physical activity and change in diet, for more than 6 months;
  • Age between 20 and 65 years old;
  • Patients without other endocrinological causes that result in morbid obesity;
  • Patients without substance use, alcohol use and other psychiatric disorders;
  • The integrity of the patient's mental status is approved by the psychiatrist.

You may not qualify if:

  • Patients who did not complete 3-year follow-up
  • Patients who are not eligible for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Bluher M. Obesity: global epidemiology and pathogenesis. Nat Rev Endocrinol. 2019 May;15(5):288-298. doi: 10.1038/s41574-019-0176-8.

    PMID: 30814686BACKGROUND

  • Powell-Wiley TM, Poirier P, Burke LE, Despres JP, Gordon-Larsen P, Lavie CJ, Lear SA, Ndumele CE, Neeland IJ, Sanders P, St-Onge MP; American Heart Association Council on Lifestyle and Cardiometabolic Health; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Epidemiology and Prevention; and Stroke Council. Obesity and Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation. 2021 May 25;143(21):e984-e1010. doi: 10.1161/CIR.0000000000000973. Epub 2021 Apr 22.

    PMID: 33882682BACKGROUND

  • Michaels AD, Mehaffey JH, Hawkins RB, Kern JA, Schirmer BD, Hallowell PT. Bariatric surgery reduces long-term rates of cardiac events and need for coronary revascularization: a propensity-matched analysis. Surg Endosc. 2020 Jun;34(6):2638-2643. doi: 10.1007/s00464-019-07036-x. Epub 2019 Aug 2.

    PMID: 31376005BACKGROUND

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Mu-Xian Yu, MD

    Tri-Service General Hospital, NDMC

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 12, 2024

Study Start

January 1, 2011

Primary Completion

December 31, 2017

Study Completion

June 30, 2023

Last Updated

February 13, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share