ObesityNCT06254339
Effects of OAGB and DJB-SG on 10-year and Lifetime Risks of MACE
An observational study of Obesity, run by National Defense Medical Center, Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- OAGB and DJB-SG
- Type of treatment
- Surgery or procedure
- How many people
- 830 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients who did not complete 3-year follow-up
- Patients who are not eligible for surgery
About this study
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.
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).
Read the 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
- Being tested
- OAGB, DJB-SG
- Keywords
- One-anastomosis gastric bypass, Duodenal-jejunal bypass with sleeve gastrectomy, Major adverse cardiovascular events, Type 2 diabetes mellitus, Obesity, Comorbidities
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OAGBProcedure or surgery
using OAGB procedure as metabolic bariatric surgery
DJB-SGProcedure or surgery
using DJB-SG procedure as metabolic bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| OAGB cohort | Application of One-anastomosis gastric bypass (OAGB) procedure stated in IFSO/ASMBS. Receives: Procedure: OAGB | |
| DJB-SG cohort | Application of Duodenojejunal bypass with sleeve gastrectomy (DJB-SG)) procedure stated in IFSO/ASMBS. Receives: Procedure: DJB-SG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
Weight reduction
Measured: 3 years
Diabetes
HbA1c change
Measured: 3 years
Hypertension
Blood pressure (SBP/BP change)
Measured: 3 years
Dyslipidemia
TG, T-CHO, LDL, HDL change
Measured: 3 years
Secondary outcomes (2)
Taiwan MACE risk prediction model
A 10-year MACE risk prediction model developed with Taiwan national data and death registry.
Measured: 10 years
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Jan 2011
- Primary completion31 Dec 2017
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 830 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuo-Feng Hsu, National Defense Medical Center, Taiwan
- Investigators
- Mu-Xian Yu, MD, Study chair, Tri-Service General Hospital, NDMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254339
- Sponsor's protocol ID
- B202105089
- Status last verified
- Feb 2024
- First submitted
- 24 Jan 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bluher M. Obesity: global epidemiology and pathogenesis. Nat Rev Endocrinol. 2019 May;15(5):288-298. doi: 10.1038/s41574-019-0176-8.
PubMed 30814686Powell-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.
PubMed 33882682Michaels 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.
PubMed 31376005
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06254339
- Acronym / sponsor ID
- B202105089
- Conditions
- Obesity
- Keywords
- One-anastomosis gastric bypass, Duodenal-jejunal bypass with sleeve gastrectomy, Major adverse cardiovascular events, Type 2 diabetes mellitus, Obesity, Comorbidities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 830 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OAGB cohort | – | Procedure: OAGBApplication of One-anastomosis gastric bypass (OAGB) procedure stated in IFSO/ASMBS. |
| DJB-SG cohort | – | Procedure: DJB-SGApplication of Duodenojejunal bypass with sleeve gastrectomy (DJB-SG)) procedure stated in IFSO/ASMBS. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (2 listed)
- Patients who did not complete 3-year follow-up
- Patients who are not eligible for surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OAGBusing OAGB procedure as metabolic bariatric surgery | Procedure or surgery | OAGB cohort |
| DJB-SGusing DJB-SG procedure as metabolic bariatric surgery | Procedure or surgery | DJB-SG cohort |
Primary outcome
Body Mass Index (BMI)
Time frame: 3 years
Weight reduction
Diabetes
Time frame: 3 years
HbA1c change
Hypertension
Time frame: 3 years
Blood pressure (SBP/BP change)
Dyslipidemia
Time frame: 3 years
TG, T-CHO, LDL, HDL change
2 secondary outcomes
Taiwan MACE risk prediction model
Time frame: 10 years
The China-PAR project model
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Background: PubMed 30814686Bluher M. Obesity: global epidemiology and pathogenesis. Nat Rev Endocrinol. 2019 May;15(5):288-298. doi: 10.1038/s41574-019-0176-8.
- Background: PubMed 33882682Powell-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.
- Background: PubMed 31376005Michaels 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mu-Xian Yu, MD study chair
Tri-Service General Hospital, NDMC
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by National Defense Medical Center, Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06254339, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.