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the Related Factors of Bariatric Surgery on Bone Mineral Density

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ClinicalTrials.gov Identifier: NCT03689816
Recruitment Status : Unknown
Verified September 2018 by Jingge Yang, First Affiliated Hospital of Jinan University.
Recruitment status was:  Active, not recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Jingge Yang, First Affiliated Hospital of Jinan University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Bone Mineral Bariatric Surgery Procedure: sleeve gastrectomy Procedure: gastric bypass Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Bariatric Surgery on Estimated Bone Mineral Density in Chinese Obesity Patients: a Retrospective Cohort Study
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: bone density
bone density
 Procedure: sleeve gastrectomy
sleeve gastrectomy

Procedure: gastric bypass
gastric bypass


Outcome Measures
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Primary Outcome Measures :
  1. Preoperative of bone density [ Time Frame: Preoperative ]
    bone density in g/cm3

  2. Postoperative of bone density at 3 months [ Time Frame: 3 months ]
    bone density in g/cm3

  3. Postoperative of bone density at 6 months [ Time Frame: 6 months ]
    bone density in g/cm3

  4. Postoperative of bone density at 1 year [ Time Frame: 1 year ]
    bone density in g/cm3


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 our country, the BMI less than 45 is majorities.

Exclusion Criteria:

-BMI<27.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689816


Locations
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China, Guangdong
The frist affiliated hospital of Jinan University
Guangzhou, Guangdong, China, 510630
Sponsors and Collaborators
First Affiliated Hospital of Jinan University
More Information
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Responsible Party: Jingge Yang, Director of bariatric surgery, First Affiliated Hospital of Jinan University
ClinicalTrials.gov Identifier: NCT03689816    
Other Study ID Numbers: FirstJinanU20180216
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018

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