Effect of Bariatric Surgery Versus Medical Therapy on Metabolic Syndrome
NCT ID: NCT05363059
Last Updated: 2024-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2010-05-01
2024-12-30
Brief Summary
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Detailed Description
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This study aimed to compare bariatric surgery(BS) with medical therapy (MT) for the management of low BMI patients with MS, approved by the ethics committee and institutional review at our hospital. 100 patients underwent bariatric surgery and 100 patients receiving medical therapy for obesity and type 2 diabetes between 2010 and 2020 at our institution. All patients met the Chinese guidelines developed by the Chinese Society for Metabolic \& Bariatric surgery (CSMBS). All patients achieve diagnostic criteria for MS, defined by the presence of at least 3 of the 5 following criteria derived from the joint interim statement (JIS) definition.
2. outcome and Data collection
All patients follow up the change of improvement in MS and its components following bariatric surgery and medical therapy, including waist circumference, hyperglycemia, hypertension, hyperlipidemia, long-term CVD risk, and medication use
3. Treatments
3.1 BS group The bariatric surgical procedures performed included Roux-en-Y gastric bypass and sleeve gastrectomy.
3.2 MT group According to the guidelines in China, patients in the medical therapy group received glucose-lowering, lipid-lowering, and antihypertensive medications, with the following targets: glycosylated hemoglobin\<7%; systolic blood pressure\<140 mmHg, diastolic blood pressure\<80 mmHg; low-density lipoprotein cholesterol\<2.6 mmol/L; and high-density lipoprotein cholesterol\>1.3 mmol/L for female or 1.0 mmol/L for male.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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BS group
The group of bariatric surgery therapy in metabolic syndrome patients.
Bariatric surgery
surgery
MT group
The group of medical therapy in metabolic syndrome patients
Hypoglycemic drugs
drug
Interventions
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Hypoglycemic drugs
drug
Bariatric surgery
surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Underwent bariatric surgery or medical therapy
* Patients met the diagnostic criteria for MS, defined criteria derived from the joint interim statement (JIS)
Exclusion Criteria
* Insulin dependent diabetes
* congenital dementia
* brain trauma
* epileps
* severe hypoglycemic coma
* cerebrovascular disease
* ischemic
* heart disease
* renal dysfunction
* alcohol abuse
* mental illness
* psychoactive substance abuse
* unwillingness to provide informed consent
18 Years
65 Years
ALL
No
Sponsors
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Third Military Medical University
OTHER
Responsible Party
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Zhiming Zhu
Director, Center for Hypertension and Metabolic Diseases, Department of Hypertension and Endocrinology, Daping Hospital
Locations
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Stryker Laparoscopy
Chongqing, Chongqing Municipality, China
Countries
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Facility Contacts
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Other Identifiers
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EBSMTMS
Identifier Type: -
Identifier Source: org_study_id
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