跳至主要内容
临床试验/NCT03689777
NCT03689777Unknown不适用

The Impact of Bariatric Surgery on Estimated Glomerular Filtration Rate in Chinese Obesity Patients: a Retrospective Cohort Study

First Affiliated Hospital of Jinan University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
1
主要终点
Postoperative of glomerular filtration rate at 6 months

研究概览

简要总结

Obesity and related metabolic diseases have become a chronic disease that is a threat to human health. Bariatric surgery can effectively and long-term reduce excess body weight and relieve related metabolic diseases, including type 2 diabetes. Laparoscopic gastric bypass surgery and laparoscopic sleeve gastrectomy are commonly used in bariatric surgery. Laparoscopic sleeve gastrectomy due to simple operation, good weight loss, and metabolic disease control effect, which is more widely used. However, there are several studies that show an increased chance of gastroesophageal reflux disease after laparoscopic sleeve gastrectomy. Long-term gastroesophageal reflux may lead to Barrett's esophagus or esophageal cancer. Nowadays, the cause of gastroesophageal reflux disease after sleeve gastrectomy is not clear and precautionary measures are not precise.

In this study, prospective randomized controlled trials were conducted to explore the possible causes of glomerular filtration rate after bariatric surgery and to explore ways to prevent glomerular filtration rate after the surgery

详细描述

With the social development and changes in the lifestyle, the incidence of obesity and type 2diabetes is rapidly increasing. In 2010, the global incidence of type 2 diabetes was 8.3% in adults, 11.6% in China and 50.1% in China. In overweight and obese people, the prevalence of type 2 diabetes also increased significantly, and the prevalence of type 2diabetes in those people with BMI> 30 reached 18.5-23%. Diabetes-induced cardiovascular and cerebrovascular diseases, renal insufficiency and other complications, seriously affecting the quality of life of the patients, endangering the safety of life, the treatment of type 2 diabetes and related complications to public health expenditure has brought tremendous pressure.

Traditional medical methods are difficult to achieve long-term and effective control of type 2 diabetes. Surgery has been shown to achieve 75-95% long-term relief of obesity in patients. Roux-en-Y gastric bypass (Roux-en-Y gastric bypass, RYGB) and laparoscopic sleeve gastrectomy are most commonly used. Among them, laparoscopic sleeve gastrectomy is relatively simple, low incidence of complications, lower operating costs, and gradually become the most important surgical methods of weight loss and metabolic disease surgery. Numerous clinical studies are shown that sleeve gastrectomy in patients with type 2 diabetes has the same therapeutic effect as gastric bypass with a complete remission rate of 70-90% for T2DM.

For the choice of surgical approach, numerous studies have shown that BMI ≧ 45, the general choice of gastric bypass surgery, BMI <45, you can choose sleeve gastrectomy. The remission rate for T2DM, sleeve gastrectomy has a good result for young patients with shorter duration. In our country, the BMI less than 45 is majorities.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

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

  • For the choice of surgical approach, numerous studies have shown that BMI ≧ 45, the general choice of gastric bypass surgery, BMI <45, you can choose sleeve gastrectomy. The remission rate for T2DM, sleeve gastrectomy has a good result for young patients with shorter duration. In our country, the BMI less than 45 is majorities.

排除标准

  • 未提供

研究组 & 干预措施

Glomerular Filtration Rate

Active Comparator

干预措施: sleeve gastrectomy (Procedure)

Glomerular Filtration Rate

Active Comparator

干预措施: gastric bypass (Procedure)

结局指标

主要结局

Postoperative of glomerular filtration rate at 6 months

时间窗: 6 months

Glomerular Filtration Rate in ml/min

Postoperative of glomerular filtration rate at 1 year

时间窗: 1 year

Glomerular Filtration Rate in ml/min

preoperative of glomerular filtration rate

时间窗: Preoperative

Glomerular Filtration Rate in ml/min

Postoperative of glomerular filtration rate at 3 months

时间窗: 3 months

Glomerular Filtration Rate in ml/min

次要结局

未报告次要终点

研究者

发起方
First Affiliated Hospital of Jinan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jingge Yang

Director of bariatric surgery

First Affiliated Hospital of Jinan University

研究点 (1)

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