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CompletedNCT07183137Updated Sep 19, 2025

Metabolic Surgery for Metabolic Syndrome

An observational study in Metabolic Syndrome (MetS), Hypertension (HTN) and Obesity, sponsored by The Third Xiangya Hospital of Central South University. Completed at 3 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by The Third Xiangya Hospital of Central South University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,581
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

Metabolic syndrome (MetS) is a combination of obesity, high blood pressure, abnormal blood sugar, and lipid disorders. It greatly increases the risk of heart disease, stroke, and type 2 diabetes. In Asian populations, MetS often appears at lower body mass index (BMI) levels than in Western countries, making it a growing public health concern even among individuals without severe obesity.

Bariatric surgery has been proven to help patients lose weight and improve blood sugar, blood pressure, and cholesterol levels. However, most studies have been done in patients with severe obesity. There is limited real-world evidence on how surgery affects patients with MetS at lower BMI levels, especially over the long term. In addition, the short-term biological changes that occur immediately after surgery are not fully understood.

This study is a multicenter prospective cohort including patients who had bariatric surgery in three hospitals in China. Patients are being followed for up to 10 years after surgery.

  • Early phase: From postoperative day 1 to 7, changes in blood pressure, glucose, and electrolytes are monitored to capture immediate metabolic effects.
  • Long-term phase: Follow-up at 3 months, 6 months, 1 year, 5 years, and 10 years is used to assess sustained improvements in weight, blood pressure, glucose, and lipid profiles.

The primary outcome is improvement or resolution of MetS, defined by standardized criteria including BMI, blood pressure, fasting glucose, and lipid levels. Secondary outcomes include changes in individual risk factors, reduction in medication use, and the proportion of patients free of MetS over time.

By providing both short-term and long-term data, this study will clarify how bariatric surgery affects the full course of MetS. The results will help identify patients who may benefit most, guide treatment recommendations, and support better prevention of cardiovascular and metabolic diseases in Asian populations.

02

Conditions studied

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

Keywords

  • bariatric surgery
  • blood pressure
  • hypertension
  • T2DM
  • obesity
03

In context

Metabolic Syndrome

1,963 studies on the registry are indexed under Metabolic Syndrome; 329 are open to participants now.

This study's enrollment of 1,581 is above the median of 200 across 458 observational studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

The Third Xiangya Hospital of Central South University is the lead sponsor of 95 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

Inclusion criteria

  • (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.

Exclusion criteria

Exclusion Criteria:

  • (1) coexisting cardiac insufficiency or renal dysfunction; (2) contraindications to bariatric surgery or anesthesia; and (3) refusal to provide informed consent.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,581 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Weight

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

  2. Body Mass Index

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

  3. Systolic blood pressure

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

  4. Diastolic blood pressure

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

  5. Status of hypertension

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

  6. Fasting blood glucose

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

  7. Total cholesterol

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

  8. Triglycerides

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

Secondary outcomes

  1. Glycated hemoglobin

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

  2. Low-density lipoprotein (LDL)

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

  3. High-density lipoprotein (HDL)

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

  4. excess weight loss (EWL%)

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

  5. Fasting insulin

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

07

Study locations

3 sites
  • China-Japan Friendship Hospital
    Beijing, Beijing Municipality 100029, China
  • Jinshazhou Hospital of Guangzhou University of Chinese Medicine
    Guangzhou, Guangdong 510168, China
  • The third xiangya hospital of Central South University
    Changsha, Hunan 410013, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07183137
Lead sponsor
The Third Xiangya Hospital of Central South University
Responsible party
Sponsor
First posted
Sep 19, 2025
Start date
Sep 1, 2010
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Sep 19, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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