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NCT Number: NCT05363059

Effect of Bariatric Surgery Versus Medical Therapy on Metabolic Syndrome

Bariatric surgery (BS) is known to improve the components of metabolic syndrome (MS) in obese patients. However, few studies have evaluated the impact of bariatric surgery versus medical therapy (MT) in patients with MS, especially in patients with low body mass index (BMI). This study aimed to assess the effect of bariatric surgery on MS in patients with low BMI by comparing BS (BMI<35 kg/m2 and BMI≥35 kg/m2) with MT (BMI<35 kg/m2). A retrospective study including patients with MS undergoing bariatric surgery and medical therapy at a single institution. We follow up the 5 years effect of bariatric surgery versus medical therapy on the remission of MS, its individual components, atherosclerotic cardiovascular disease (ASCVD) risk, and medication used.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

  • Study design and patients

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.

  • 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

  • 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.

Who can participate

Healthy volunteers accepted: No

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

  • Inclusion Criteria:
  • BMI<35 kg/m^2
  • Underwent bariatric surgery or medical therapy
  • Patients met the diagnostic criteria for MS, defined criteria derived from the joint interim statement (JIS)
  • Exclusion Criteria:
  • Patients who failed to follow up
  • 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

Treatment and study plan

Hypoglycemic drugs

Drug

drug

Other names: antihypertensive drugs, lipid-lowering drugs

bariatric surgery

Procedure

surgery

Other names: metabolic surgery

Primary outcomes

  1. Change in metabolic parameters from baseline to 5 years.

    Time frame: baseline to 5 years

    Waist circumference(cm)

  2. Change in metabolic parameters from baseline to 5 years.

    Time frame: baseline to 5 years

    body mass index(kg/m^2)

Secondary outcomes

  1. Change in glycosylated hemoglobin from baseline to 5 years.

    Time frame: baseline to 5 years

    glycosylated hemoglobin(%)

  2. Change in plasma glucose from baseline to 5 years.

    Time frame: baseline to 5 years

    Fasting plasma glucose(mmol/l),

  3. Change in blood lipids from baseline to 5 years.

    Time frame: baseline to 5 years

    total cholesterol(mmol/l), triglycerides(mmol/l), high-density lipoprotein cholesterol(mmol/l), low-density lipoprotein cholesterol(mmol/l)

  4. Changes of CVD risk

    Time frame: baseline to 5 years

    10-year and lifetime ASCVD risk calculated by the China-PAR equation. Evaluation metrics include sex, age, region of residence (South or North), waist circumference, total cholesterol, HDL cholesterol, systolic blood pressure, diastolic blood pressure, whether taking antihypertensive drugs, whether diabetic, whether smoker, family history of cardiovascular and cerebrovascular.

  5. Hypoglycemic drugs use

    Time frame: baseline to 5 years

    The number and daily drug dose of hypoglycemic drugs

  6. Antihypertensive drugs use

    Time frame: baseline to 5 years

    The number and daily drug dose of antihypertensive drugs

  7. Lipid-lowering drugs use

    Time frame: baseline to 5 years

    The number and daily drug dose of lipid-lowering drugs

Sponsors and collaborators

Lead sponsor

Third Military Medical University

Other

Registry information

Official study title

Army Medical University

Acronym: EBSMTMS

Important dates

Study start
2010
Primary completion
2024
Study completion
2024
First posted
May 5, 2022
Registry last updated
Aug 20, 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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