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Clinical Trials/NCT03689816
NCT03689816UnknownNot Applicable

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

First Affiliated Hospital of Jinan University1 site in 1 country1,000 target enrollmentStarted: April 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
1,000
Locations
1
Primary Endpoint
Postoperative of bone density at 3 months

Study Overview

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 causes of bone mineral after bariatric surgery and to explore ways to prevent bone mineral after bariatric surgery.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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 our country, the BMI less than 45 is majorities.

Exclusion Criteria

  • Not provided

Arms & Interventions

bone density

Experimental

bone density

Intervention: sleeve gastrectomy (Procedure)

bone density

Experimental

bone density

Intervention: gastric bypass (Procedure)

Outcomes

Primary Outcomes

Postoperative of bone density at 3 months

Time Frame: 3 months

bone density in g/cm3

Postoperative of bone density at 6 months

Time Frame: 6 months

bone density in g/cm3

Preoperative of bone density

Time Frame: Preoperative

bone density in g/cm3

Postoperative of bone density at 1 year

Time Frame: 1 year

bone density in g/cm3

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
First Affiliated Hospital of Jinan University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jingge Yang

Director of bariatric surgery

First Affiliated Hospital of Jinan University

Study Sites (1)

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