the Related Factors of Bariatric Surgery on Lipidemia

September 26, 2018 updated by: Jingge Yang, First Affiliated Hospital of Jinan University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • The frist affiliated hospital of Jinan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lipidemia
Procedure: gastric bypass
gastric bypass
Procedure: sleeve gastrectomy
sleeve gastrectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
preoperative of choleaterol
Time Frame: Preoperate
choleaterol in ml/dl
Preoperate
Postoperative of choleaterol at 3 months
Time Frame: 3 months
choleaterol in ml/dl
3 months
Postoperative of choleaterol at 6 months
Time Frame: 6 months
choleaterol in ml/dl
6 months
Postoperative of choleaterol at 1 year
Time Frame: 1 year
choleaterol in ml/dl
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative of triglyceride
Time Frame: Preoperative
triglyceride in ml/dl
Preoperative
Postoperative of triglyceride at 3 months
Time Frame: 3 months
triglyceride in ml/dl
3 months
Postoperative of triglyceride at 6 months
Time Frame: 6 months
triglyceride in ml/dl
6 months
Postoperative of triglyceride at 1 year
Time Frame: 1 year
triglyceride in ml/dl
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Jinan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

June 3, 2018

First Submitted That Met QC Criteria

September 26, 2018

First Posted (Actual)

September 28, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2018

Last Update Submitted That Met QC Criteria

September 26, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstJinanU20180214

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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