NCT06254339

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 830 (actual)
• Sponsor: National Defense Medical Center, Taiwan · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
PROCEDURE	OAGB	using OAGB procedure as metabolic bariatric surgery
PROCEDURE	DJB-SG	using DJB-SG procedure as metabolic bariatric surgery

Timeline

• Start date: 2011-01-01
• Primary completion: 2017-12-31
• Completion: 2023-06-30
• First posted: 2024-02-12
• Last updated: 2024-02-13