Clinical trial NCT06254339: Effects of OAGB and DJB-SG on 10-year and Lifetime Risks of MACE
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: One-anastomosis gastric bypass
Duodenal-jejunal bypass with sleeve gastrectomy
Major adverse cardiovascular events
Type 2 diabetes mellitus
Obesity
Comorbidities
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 830
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_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.

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 3 years
measure: Diabetes
timeFrame: 3 years
measure: Hypertension
timeFrame: 3 years
measure: Dyslipidemia
timeFrame: 3 years
Secondary outcomes:
measure: Taiwan MACE risk prediction model
timeFrame: 10 years
measure: The China-PAR project model
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
affiliation: Tri-Service General Hospital, NDMC
name: Mu-Xian Yu, MD
role: STUDY_CHAIR
References:
citation: Bluher M. Obesity: global epidemiology and pathogenesis. Nat Rev Endocrinol. 2019 May;15(5):288-298. doi: 10.1038/s41574-019-0176-8.
citation: 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.
citation: 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.