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

Obesity Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06254339
• Other study ID #: B202105089
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2024
• Source: National Defense Medical Center, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 830
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• OAGB
using OAGB procedure as metabolic bariatric surgery
• DJB-SG
using DJB-SG procedure as metabolic bariatric surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Defense Medical Center, Taiwan

References & Publications (3)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index (BMI)	Weight reduction	3 years
Primary	Diabetes	HbA1c change	3 years
Primary	Hypertension	Blood pressure (SBP/BP change)	3 years
Primary	Dyslipidemia	TG, T-CHO, LDL, HDL change	3 years
Secondary	Taiwan MACE risk prediction model	A 10-year MACE risk prediction model developed with Taiwan national data and death registry.	10 years
Secondary	The China-PAR project model	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