Metabolic Surgery for Metabolic Syndrome

NCT07183137 | Completed

• 1 other identifier: 2010-S008
• Study Type: observational
• Target: 1,581
• Locations: 1 country
• Sites: 3

Brief Summary

This study is designed to understand how bariatric surgery affects patients with metabolic syndrome over both the short and long term. We will track changes in blood pressure and other health indicators for up to 10 years after surgery. The goal is to see whether surgery can provide lasting benefits for controlling blood pressure and improving overall health in patients with metabolic syndrome.

Conditions

Metabolic Syndrome (MetS); Hypertension (HTN); Obesity; T2; T2DM; Bariatric Surgery; Metabolic Surgery

Keywords

bariatric surgery; blood pressure; hypertension; T2DM; obesity

Outcome Measures

Primary Outcomes (8)

• Weight

  postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years

• Body Mass Index

  postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years

• Systolic blood pressure

  postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years

• Diastolic blood pressure

  postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years

• Status of hypertension

  postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years

• Fasting blood glucose

  postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years

• Total cholesterol

  postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years

• Triglycerides

  postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years

Secondary Outcomes (5)

• Glycated hemoglobin

  postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years

• Low-density lipoprotein (LDL)

  postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years

• High-density lipoprotein (HDL)

  postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years

• excess weight loss (EWL%)

  postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years

• Fasting insulin

  postoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years

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

The study population consists of adult patients aged 18 to 65 years who were scheduled to undergo bariatric surgery, including laparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG), at three participating medical centers in China. Patients were selected based on guideline-based indications for bariatric surgery at the time of recruitment. For the primary analysis, only patients with hypertension were included, defined as meeting at least one of the following criteria: (1) systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg; (2) self-reported or physician-diagnosed hypertension; or (3) current use of antihypertensive medications. Patients with coexisting cardiac insufficiency, renal dysfunction, contraindications to surgery or anesthesia, or who declined participation were excluded. Additional exclusions during the data analysis phase included patients who experienced severe postoperative adverse events within 7 days, had fewer tha

You may qualify if:

• (1) aged 18-65 years; (2) scheduled to undergo bariatric surgery, including laparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG); and (3) met the guideline-based indications for surgery at the time of operation.

You may not qualify if:

• (1) coexisting cardiac insufficiency or renal dysfunction; (2) contraindications to bariatric surgery or anesthesia; and (3) refusal to provide informed consent.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (3)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

Jinshazhou Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510168, China

Location

The third xiangya hospital of Central South University

Changsha, Hunan, 410013, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood and urine

MeSH Terms

Conditions

Metabolic Syndrome; Hypertension; Obesity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: September 19, 2025
• Study Start: September 1, 2010
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

CN (3)