Effects of OAGB and DJB-SG on 10-year and Lifetime Risks of MACE
The Effect of MBS on Outcomes and Reduction of the 10-year and Lifetime Risks of MACE: Analysis of 224 Patients Undergoing OAGB and DJB-SG During a 7-year Period.
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
OAGB cohort
Application of One-anastomosis gastric bypass (OAGB) procedure stated in IFSO/ASMBS.
|
using OAGB procedure as metabolic bariatric surgery
|
|
DJB-SG cohort
Application of Duodenojejunal bypass with sleeve gastrectomy (DJB-SG)) procedure stated in IFSO/ASMBS.
|
using DJB-SG procedure as metabolic bariatric surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass Index (BMI)
Time Frame: 3 years
|
Weight reduction
|
3 years
|
|
Diabetes
Time Frame: 3 years
|
HbA1c change
|
3 years
|
|
Hypertension
Time Frame: 3 years
|
Blood pressure (SBP/BP change)
|
3 years
|
|
Dyslipidemia
Time Frame: 3 years
|
TG, T-CHO, LDL, HDL change
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Taiwan MACE risk prediction model
Time Frame: 10 years
|
A 10-year MACE risk prediction model developed with Taiwan national data and death registry.
|
10 years
|
|
The China-PAR project model
Time Frame: 10 years
|
A 10-year and lifetime prediction model for atherosclerotic cardiovascular disease risk in Chinese population, developed within the context of the Chinese population on a national scale.
|
10 years
|
Collaborators and Investigators
Investigators
- Study Chair: Mu-Xian Yu, MD, Tri-Service General Hospital, NDMC
Publications and helpful links
General Publications
- Bluher M. Obesity: global epidemiology and pathogenesis. Nat Rev Endocrinol. 2019 May;15(5):288-298. doi: 10.1038/s41574-019-0176-8.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B202105089
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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