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Completed

NCT Number: NCT06254339

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OAGB

Procedure

using OAGB procedure as metabolic bariatric surgery

DJB-SG

Procedure

using DJB-SG procedure as metabolic bariatric surgery

Primary outcomes

  1. Body Mass Index (BMI)

    Time frame: 3 years

    Weight reduction

  2. Diabetes

    Time frame: 3 years

    HbA1c change

  3. Hypertension

    Time frame: 3 years

    Blood pressure (SBP/BP change)

  4. Dyslipidemia

    Time frame: 3 years

    TG, T-CHO, LDL, HDL change

Secondary outcomes

  1. Taiwan MACE risk prediction model

    Time frame: 10 years

    A 10-year MACE risk prediction model developed with Taiwan national data and death registry.

  2. 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.

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2017
Study completion
2023
First posted
Feb 12, 2024
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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