An interventional study of sleeve gastrectomy and gastric bypass in Liver Function and Bariatric Surgery, sponsored by First Affiliated Hospital of Jinan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-28.
Sponsored by First Affiliated Hospital of Jinan University · Not applicable, Interventional, and Treatment
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 liver funnction after bariatric surgery and to explore ways to prevent liver functione after bariatric surgery
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, participants can choose sleeve gastrectomy. The remission rate for T2DM, sleeve gastrectomy has a good result for young patients with shorter duration. In China, the BMI less than 45 is majorities.
According to the previous survey in 2012, the newly diagnosed diabetes patients in China constituted more than half of all diabetic patients. Since bariatric surgery is relatively simple, so bariatric surgery is easier to popularize in China and has wide application prospect.
First Affiliated Hospital of Jinan University is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
liver function
Procedure: sleeve gastrectomy · Procedure: gastric bypass
sleeve gastrectomy
gastric bypass
preoperative of aminotransferase aspartate
Aminotransferase aspartate in U/L
Time frame: Preoperative
Postoperative of aminotransferase aspartate at 3 months
Aminotransferase aspartate in U/L
Time frame: 3 months
Postoperative of aminotransferase aspartate at 6 months
Aminotransferase aspartate in U/L
Time frame: 6 months
Postoperative of aminotransferase aspartate at 1 year
Aminotransferase aspartate in U/L
Time frame: 1 year
preoperative of alanine aminotransferase
Alanine aminotransferase in U/L
Time frame: Preoperative
Postoperative of alanine aminotransferase at 3 months
Alanine aminotransferase in U/L
Time frame: 3 months
Postoperative of alanine aminotransferase at 6 months
Alanine aminotransferase in U/L
Time frame: 6 months
Postoperative of alanine aminotransferase at 1 year
Alanine aminotransferase in U/L
Time frame: 1 year
Started Apr 2018 (actual). Primary completion is estimated for Dec 2018, 8 months after the start.
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This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital of Jinan University