Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03689790
Other study ID # FirstJinanU20180213
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date December 2019

Study information

Verified date September 2018
Source First Affiliated Hospital of Jinan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 liver funnction after bariatric surgery and to explore ways to prevent liver functione after bariatric surgery


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, 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1000
Est. completion date December 2019
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 the investigator's country, the BMI less than 45 is majorities.

Exclusion Criteria:

- BMI<27.5

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
sleeve gastrectomy
sleeve gastrectomy
gastric bypass
gastric bypass

Locations

Country Name City State
China The frist affiliated hospital of Jinan University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital of Jinan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary preoperative of aminotransferase aspartate Aminotransferase aspartate in U/L Preoperative
Primary Postoperative of aminotransferase aspartate at 3 months Aminotransferase aspartate in U/L 3 months
Primary Postoperative of aminotransferase aspartate at 6 months Aminotransferase aspartate in U/L 6 months
Primary Postoperative of aminotransferase aspartate at 1 year Aminotransferase aspartate in U/L 1 year
Secondary preoperative of alanine aminotransferase Alanine aminotransferase in U/L Preoperative
Secondary Postoperative of alanine aminotransferase at 3 months Alanine aminotransferase in U/L 3 months
Secondary Postoperative of alanine aminotransferase at 6 months Alanine aminotransferase in U/L 6 months
Secondary Postoperative of alanine aminotransferase at 1 year Alanine aminotransferase in U/L 1 year
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04517591 - Reducing Sedentary Time in Bariatric: The Take a STAND for Health Study N/A
Active, not recruiting NCT04433338 - The PREBA Study: Effect of Preoperative Weight Loss With a 14-day Low-calorie Diet on Surgical Procedure and Outcomes in Patients Undergoing RYGB Surgery N/A
Completed NCT05854875 - Diabetes Remission After RYGBP and RYGBP With Fundus Resection N/A
Recruiting NCT06460233 - Blood Pressure Changes After Bariatric Surgery
Completed NCT00535600 - Effects of Bariatric Surgery on Insulin
Withdrawn NCT04771247 - Endoscopic Cardiac Band Ligation for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy N/A
Not yet recruiting NCT03203161 - Registry on Obesity Surgery in Adolescents
Enrolling by invitation NCT02552433 - Complications in Body Contouring Surgery
Completed NCT02525016 - Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery Phase 3
Recruiting NCT01984762 - Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in the Treatment of Type 2 Diabetes Mellitus. N/A
Not yet recruiting NCT01652105 - Randomized Trial of Preoperative Diets Before Bariatric Surgery N/A
Completed NCT00989157 - Effects of Gastric Bypass on Blood Levels of Duloxetine Phase 3
Completed NCT03609632 - Understanding Hypoglycaemia After Bariatric Surgery N/A
Completed NCT05454696 - Online Clinic Pilates Exercises in Patients Undergoing Bariatric Surgery N/A
Completed NCT04040647 - Tolerance of Early Postoperative Mobilization and Ambulation
Recruiting NCT04297306 - Virtual Reality Exercise Gaming in Patients Awaiting Bariatric Surgery N/A
Recruiting NCT05428618 - Mobile Application for Bariatric Surgery Patients N/A
Not yet recruiting NCT03900481 - Use of an Endoluminal-suturing Device for Endoscopic Gastric Reduction as an Aid for Class I Obesity, or Class II Obesity Without Comorbidity N/A
Not yet recruiting NCT03975244 - Semi-supervised Exercise Program Before Bariatric Surgery N/A
Recruiting NCT06157606 - Prediction Model for Inadequate Weight Loss After Sleeve Gastrectomy