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the Related Factors of Bariatric Surgery on Glomerular Filtration Rate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03689777
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

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 glomerular filtration rate after bariatric surgery and to explore ways to prevent glomerular filtration rate after the surgery


Condition or disease Intervention/treatment Phase
Bariatric Surgery Glomerular Filtration Rate Procedure: sleeve gastrectomy Procedure: gastric bypass Not Applicable

Detailed Description:

With the social development and changes in the lifestyle, the incidence of obesity and type 2diabetes is rapidly increasing. In 2010, the global incidence of type 2 diabetes was 8.3% in adults, 11.6% in China and 50.1% in China. In overweight and obese people, the prevalence of type 2 diabetes also increased significantly, and the prevalence of type 2diabetes in those people with BMI> 30 reached 18.5-23%. Diabetes-induced cardiovascular and cerebrovascular diseases, renal insufficiency and other complications, seriously affecting the quality of life of the patients, endangering the safety of life, the treatment of type 2 diabetes and related complications to public health expenditure has brought tremendous pressure.

Traditional medical methods are difficult to achieve long-term and effective control of type 2 diabetes. Surgery has been shown to achieve 75-95% long-term relief of obesity in patients. Roux-en-Y gastric bypass (Roux-en-Y gastric bypass, RYGB) and laparoscopic sleeve gastrectomy are most commonly used. Among them, laparoscopic sleeve gastrectomy is relatively simple, low incidence of complications, lower operating costs, and gradually become the most important surgical methods of weight loss and metabolic disease surgery. Numerous clinical studies are shown that sleeve gastrectomy in patients with type 2 diabetes has the same therapeutic effect as gastric bypass with a complete remission rate of 70-90% for T2DM.

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.

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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: Prevention
Official Title: The Impact of Bariatric Surgery on Estimated Glomerular Filtration Rate in Chinese Obesity Patients: a Retrospective Cohort Study
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Glomerular Filtration Rate Procedure: sleeve gastrectomy
sleeve gastrectomy

Procedure: gastric bypass
gastric bypass




Primary Outcome Measures :
  1. preoperative of glomerular filtration rate [ Time Frame: Preoperative ]
    Glomerular Filtration Rate in ml/min

  2. Postoperative of glomerular filtration rate at 3 months [ Time Frame: 3 months ]
    Glomerular Filtration Rate in ml/min

  3. Postoperative of glomerular filtration rate at 6 months [ Time Frame: 6 months ]
    Glomerular Filtration Rate in ml/min

  4. Postoperative of glomerular filtration rate at 1 year [ Time Frame: 1 year ]
    Glomerular Filtration Rate in ml/min



Information from the National Library of Medicine

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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<27.5


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): NCT03689777


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
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Responsible Party: Jingge Yang, Director of bariatric surgery, First Affiliated Hospital of Jinan University
ClinicalTrials.gov Identifier: NCT03689777    
Other Study ID Numbers: FirstJinanU20180212
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