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Metabolic Surgery for Metabolic Syndrome

A Prospective Observational Study on Metabolic Surgery for the Treatment of Metabolic Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07183137
Enrollment
1581
Registered
2025-09-19
Start date
2010-09-01
Completion date
2019-12-31
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

bariatric surgery, blood pressure, hypertension, T2DM, obesity

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.

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.

Interventions

None listed

Sponsors

The Third Xiangya Hospital of Central South University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

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

Design outcomes

Primary

MeasureTime frame
Triglyceridespostoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Systolic blood pressurepostoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Diastolic blood pressurepostoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Status of hypertensionpostoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Fasting blood glucosepostoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Total cholesterolpostoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Weightpostoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Body Mass Indexpostoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years

Secondary

MeasureTime frame
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 insulinpostoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years
Glycated hemoglobinpostoperative day 1 to 7, 3 months, 6 months, 1 year, 5 years, and 10 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026