Effect of Bariatric Surgery Versus Medical Therapy on Metabolic Syndrome

NCT05363059 | Recruiting

• 1 other identifier: EBSMTMS
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome

Keywords

metabolic syndrome; Medical therapy; Bariatric surgery; body mass index

Outcome Measures

Primary Outcomes (2)

• Change in metabolic parameters from baseline to 5 years.

  Waist circumference(cm)

  baseline to 5 years

• Change in metabolic parameters from baseline to 5 years.

  body mass index(kg/m\^2)

  baseline to 5 years

Secondary Outcomes (7)

• Change in glycosylated hemoglobin from baseline to 5 years.

  baseline to 5 years

• Change in plasma glucose from baseline to 5 years.

  baseline to 5 years

• Change in blood lipids from baseline to 5 years.

  baseline to 5 years

• Changes of CVD risk

  baseline to 5 years

• Hypoglycemic drugs use

  baseline to 5 years

Study Arms (2)

BS group

The group of bariatric surgery therapy in metabolic syndrome patients.

Procedure: Bariatric surgery

MT group

The group of medical therapy in metabolic syndrome patients

Drug: Hypoglycemic drugs

Interventions

Hypoglycemic drugs DRUG

drug

Also known as: antihypertensive drugs, lipid-lowering drugs

MT group

Bariatric surgery PROCEDURE

surgery

Also known as: metabolic surgery

BS group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients underwent bariatric surgery or medical therapy for metabolic syndrome between 2010 and 2020 at our institution.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Stryker Laparoscopy

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Hypoglycemic Agents; Antihypertensive Agents; Bariatric Surgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Cardiovascular Agents; Therapeutic Uses; Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Hypertension and Metabolic Diseases, Department of Hypertension and Endocrinology, Daping Hospital

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: May 5, 2022
• Study Start: May 1, 2010
• Primary Completion: September 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)