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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03689803
Other study ID # FirstJinanU20180214
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 change of lipidemia after bariatric surgery and to explore ways to prevent bariatric surgery after bariatric surgery.


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 choleaterol choleaterol in ml/dl Preoperate
Primary Postoperative of choleaterol at 3 months choleaterol in ml/dl 3 months
Primary Postoperative of choleaterol at 6 months choleaterol in ml/dl 6 months
Primary Postoperative of choleaterol at 1 year choleaterol in ml/dl 1 year
Secondary Preoperative of triglyceride triglyceride in ml/dl Preoperative
Secondary Postoperative of triglyceride at 3 months triglyceride in ml/dl 3 months
Secondary Postoperative of triglyceride at 6 months triglyceride in ml/dl 6 months
Secondary Postoperative of triglyceride at 1 year triglyceride in ml/dl 1 year
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