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

Completed

• Conditions: Obesity
• Interventions: Procedure: OAGB; Procedure: DJB-SG

• Registration Number: NCT06254339
• Lead Sponsor: National Defense Medical Center, Taiwan

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.

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2017-12-31
• Study Completion: 2023-06-30
• Study First Submitted: 2024-01-24
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-09
• Last Update Submitted: 2024-02-09
• Study First Posted: 2024-02-12
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 830

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OAGB cohort	OAGB	Application of One-anastomosis gastric bypass (OAGB) procedure stated in IFSO/ASMBS.
DJB-SG cohort	DJB-SG	Application of Duodenojejunal bypass with sleeve gastrectomy (DJB-SG)) procedure stated in IFSO/ASMBS.

Primary Outcome Measures

Name	Time	Method
Diabetes	3 years	HbA1c change
Hypertension	3 years	Blood pressure (SBP/BP change)
Dyslipidemia	3 years	TG, T-CHO, LDL, HDL change
Body Mass Index (BMI)	3 years	Weight reduction

Secondary Outcome Measures

Name	Time	Method
Taiwan MACE risk prediction model	10 years	A 10-year MACE risk prediction model developed with Taiwan national data and death registry.
The China-PAR project model	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.