NCT03689803

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 28, 2018

Status Verified

September 1, 2018

Enrollment Period

8 months

First QC Date

June 3, 2018

Last Update Submit

September 26, 2018

Conditions

Outcome Measures

Primary Outcomes (4)

  • preoperative of choleaterol

    choleaterol in ml/dl

    Preoperate

  • Postoperative of choleaterol at 3 months

    choleaterol in ml/dl

    3 months

  • Postoperative of choleaterol at 6 months

    choleaterol in ml/dl

    6 months

  • Postoperative of choleaterol at 1 year

    choleaterol in ml/dl

    1 year

Secondary Outcomes (4)

  • Preoperative of triglyceride

    Preoperative

  • Postoperative of triglyceride at 3 months

    3 months

  • Postoperative of triglyceride at 6 months

    6 months

  • Postoperative of triglyceride at 1 year

    1 year

Study Arms (1)

Lipidemia

ACTIVE COMPARATOR
Procedure: sleeve gastrectomyProcedure: gastric bypass

Interventions

sleeve gastrectomy.

Lipidemia

gastric bypass

Lipidemia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • BMI\<27.5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The frist affiliated hospital of Jinan University

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of bariatric surgery

Study Record Dates

First Submitted

June 3, 2018

First Posted

September 28, 2018

Study Start

April 1, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

September 28, 2018

Record last verified: 2018-09

Locations