the Related Factors of Bariatric Surgery on Glomerular Filtration Rate
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03689777|
Recruitment Status : Unknown
Verified September 2018 by Jingge Yang, First Affiliated Hospital of Jinan University.
Recruitment status was: Active, not recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Bariatric Surgery Glomerular Filtration Rate||Procedure: sleeve gastrectomy Procedure: gastric bypass||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of Bariatric Surgery on Estimated Glomerular Filtration Rate in Chinese Obesity Patients: a Retrospective Cohort Study|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
|Active Comparator: Glomerular Filtration Rate||
Procedure: sleeve gastrectomy
Procedure: gastric bypass
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689777
|The frist affiliated hospital of Jinan University|
|Guangzhou, Guangdong, China, 510630|