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Clinical Trials/NCT03689777
NCT03689777UnknownNot Applicable

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

First Affiliated Hospital of Jinan University1 site in 1 country1,000 target enrollmentStarted: January 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
1,000
Locations
1
Primary Endpoint
Postoperative of glomerular filtration rate at 6 months

Study Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Not provided

Arms & Interventions

Glomerular Filtration Rate

Active Comparator

Intervention: sleeve gastrectomy (Procedure)

Glomerular Filtration Rate

Active Comparator

Intervention: gastric bypass (Procedure)

Outcomes

Primary Outcomes

Postoperative of glomerular filtration rate at 6 months

Time Frame: 6 months

Glomerular Filtration Rate in ml/min

Postoperative of glomerular filtration rate at 1 year

Time Frame: 1 year

Glomerular Filtration Rate in ml/min

preoperative of glomerular filtration rate

Time Frame: Preoperative

Glomerular Filtration Rate in ml/min

Postoperative of glomerular filtration rate at 3 months

Time Frame: 3 months

Glomerular Filtration Rate in ml/min

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
First Affiliated Hospital of Jinan University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jingge Yang

Director of bariatric surgery

First Affiliated Hospital of Jinan University

Study Sites (1)

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