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LSG in Obese Patients

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ClinicalTrials.gov Identifier: NCT04548232
Recruitment Status : Completed
First Posted : September 14, 2020
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Shen Qu, Shanghai 10th People's Hospital

Study Description
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Brief Summary:
297 patients with obesity and 43 healthy individuals with normal BMI were enrolled. 82 patients underwent LSG. Anthropometrics, glucose-lipid metabolic markers, and hepatic steatosis assessed by FibroScan(CAP value and E value) were measured baseline, and again at a time interval of 6 months and 1 year follow up after surgery.

Condition or disease Intervention/treatment
Obesity Procedure: LSG

Study Design
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Study Type : Observational
Actual Enrollment : 297 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Shanghai Tenth People's Hospital
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : January 1, 2020
Groups and Cohorts
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Intervention Details:
  • Procedure: LSG
    bariatric surgery

Outcome Measures
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Primary Outcome Measures :
  1. hepatic steatosis [ Time Frame: 2017-2019 ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
297 subjects with obesity or overweight
Criteria

Inclusion Criteria:

1) age ranged from 16~65 years old, 2) BMI over 37.5 kg/m2, or BMI over 32.5 kg/m2 with diabetes which meets the recommended cutoff for bariatric surgery of the Guidelines for surgical treatment of obesity accompanied with or without type 2 diabetes in China. -

Exclusion Criteria:

  • 1) secondary cause of obesity such as hypothalamic obesity, Cushing syndrome, and hypophysis dysfunction, etc., 2) pregnancy or lactation, 3) contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesions, etc., 4) severe heart, liver and kidney dysfunction, 5) organic and systemic diseases intolerant of surgery.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Shen Qu, Professor, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT04548232    
Other Study ID Numbers: 123100004250085347
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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