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the Related Factors of Bariatric Surgery on Lipidemia

Primary Purpose

Bariatric Surgery, Lipidemia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
sleeve gastrectomy
gastric bypass
Sponsored by
First Affiliated Hospital of Jinan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bariatric Surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The frist affiliated hospital of Jinan University

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Lipidemia

Arm Description

Outcomes

Primary Outcome Measures

preoperative of choleaterol
choleaterol in ml/dl
Postoperative of choleaterol at 3 months
choleaterol in ml/dl
Postoperative of choleaterol at 6 months
choleaterol in ml/dl
Postoperative of choleaterol at 1 year
choleaterol in ml/dl

Secondary Outcome Measures

Preoperative of triglyceride
triglyceride in ml/dl
Postoperative of triglyceride at 3 months
triglyceride in ml/dl
Postoperative of triglyceride at 6 months
triglyceride in ml/dl
Postoperative of triglyceride at 1 year
triglyceride in ml/dl

Full Information

First Posted
June 3, 2018
Last Updated
September 26, 2018
Sponsor
First Affiliated Hospital of Jinan University
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1. Study Identification

Unique Protocol Identification Number
NCT03689803
Brief Title
the Related Factors of Bariatric Surgery on Lipidemia
Official Title
The Impact of Bariatric Surgery on Estimated Lipidemia in Chinese Obesity Patients: a Retrospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Jinan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery, Lipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lipidemia
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
sleeve gastrectomy
Intervention Description
sleeve gastrectomy.
Intervention Type
Procedure
Intervention Name(s)
gastric bypass
Intervention Description
gastric bypass
Primary Outcome Measure Information:
Title
preoperative of choleaterol
Description
choleaterol in ml/dl
Time Frame
Preoperate
Title
Postoperative of choleaterol at 3 months
Description
choleaterol in ml/dl
Time Frame
3 months
Title
Postoperative of choleaterol at 6 months
Description
choleaterol in ml/dl
Time Frame
6 months
Title
Postoperative of choleaterol at 1 year
Description
choleaterol in ml/dl
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Preoperative of triglyceride
Description
triglyceride in ml/dl
Time Frame
Preoperative
Title
Postoperative of triglyceride at 3 months
Description
triglyceride in ml/dl
Time Frame
3 months
Title
Postoperative of triglyceride at 6 months
Description
triglyceride in ml/dl
Time Frame
6 months
Title
Postoperative of triglyceride at 1 year
Description
triglyceride in ml/dl
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
The frist affiliated hospital of Jinan University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China

12. IPD Sharing Statement

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the Related Factors of Bariatric Surgery on Lipidemia

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