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临床试验/NCT07183137
NCT07183137已完成不适用

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

The Third Xiangya Hospital of Central South University3 个研究点 分布在 1 个国家目标入组 1,581 人开始时间: 2010年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,581
试验地点
3
主要终点
Weight

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (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.

排除标准

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

结局指标

主要结局

Weight

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

Body Mass Index

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

Systolic blood pressure

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

Diastolic blood pressure

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

Status of hypertension

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

Fasting blood glucose

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

Total cholesterol

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

Triglycerides

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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