Effects of OAGB and DJB-SG on 10-year and Lifetime Risks of MACE

NCT ID: NCT06254339

Last Updated: 2024-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

830 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2023-06-30

Brief Summary

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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).

Detailed Description

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Metabolic bariatric surgery (MBS) offers enduring weight reduction and alleviation of obesity-related comorbidities, including dyslipidemia, type 2 diabetes (T2D), hypertension (HTN), and major adverse cardiovascular events (MACE). Long-term data on one anastomosis gastric bypass (OAGB) and duodenal-jejunal bypass with sleeve gastrectomy (DJB-SG) is lacking, necessitating this investigation. In this multicenter prospectively-collected retrospective observational study, patients with complete follow-up data at various intervals up to 3 years after surgery were included in the final analysis. The study's primary focus was to evaluate the long-term safety, efficacy, and durability of OAGB and DJB-SG in promoting weight loss and T2D remission. Additionally, changes in 10-year and lifetime risks of MACE before and 3-year after surgery were assessed using the Taiwan MACE risk prediction model and the China-PAR project model based on Taiwan national electronic health records and a large Chinese participant dataset, respectively.

Hypothesis: This study contributes to providing valuable information in terms of the impacts of OAGB and DJB-SG on patients with obesity and associated diseases.

Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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OAGB cohort

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

OAGB

Intervention Type PROCEDURE

using OAGB procedure as metabolic bariatric surgery

DJB-SG cohort

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

DJB-SG

Intervention Type PROCEDURE

using DJB-SG procedure as metabolic bariatric surgery

Interventions

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OAGB

using OAGB procedure as metabolic bariatric surgery

Intervention Type PROCEDURE

DJB-SG

using DJB-SG procedure as metabolic bariatric surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Patients who did not complete 3-year follow-up
* Patients who are not eligible for surgery
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Defense Medical Center, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Kuo-Feng Hsu

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mu-Xian Yu, MD

Role: STUDY_CHAIR

Tri-Service General Hospital, NDMC

References

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

Reference Type BACKGROUND
PMID: 30814686 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33882682 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31376005 (View on PubMed)

Other Identifiers

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B202105089

Identifier Type: -

Identifier Source: org_study_id

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