the Related Factors of Bariatric Surgery on Bone Mineral Density

Bariatric Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03689816
• Other study ID #: FirstJinanU20180216
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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 causes of bone mineral after bariatric surgery and to explore ways to prevent bone mineral 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 our country, the BMI less than 45 is majorities.

Exclusion Criteria:

-BMI<27.

Related Conditions & MeSH terms

• Bariatric Surgery
• Bone Mineral

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 bone density	bone density in g/cm3	Preoperative
Primary	Postoperative of bone density at 3 months	bone density in g/cm3	3 months
Primary	Postoperative of bone density at 6 months	bone density in g/cm3	6 months
Primary	Postoperative of bone density at 1 year	bone density in g/cm3	1 year