Effect of Sarcopenic Obesity on Weight Loss Outcomes and Quality of Life After Laparoscopic Sleeve Gastrectomy

April 12, 2023 updated by: Chang-Ming Huang, Prof., Fujian Medical University
The purpose of this study is to assess the impact of sarcopenic obesity (SO) on weight loss outcomes and improvement of quality of life after laparoscopic sleeve gastrectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sarcopenic obesity is a state in which a lack of muscle mass and strength coexists with an increase in fat mass, and it may affect the health outcome of people with obesity after laparoscopic sleeve gastrectomy (LSG).No studies have reported differences in weight loss outcomes between patients with SO and those with non-sarcopenic obesity (NSO) after LSG. Therefore, this study aimed to systematically evaluate the differences in weight loss and quality of life (QOL) evaluation between patients with SO and NSO after LSG and provide high-level evidence-based medical evidence for the impact of SO on weight loss in the obese population and refinement of follow-up strategies.

Study Type

Observational

Enrollment (Actual)

245

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Chang-ming Huang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This retrospective monocentric study included 260 obese patients who underwent LSG between January 2015 and July 2022 at the Department of Gastric Surgery, Fujian Medical University Union Hospital. All patients underwent a thorough multidisciplinary evaluation (an endocrinologist, dietician, and bariatric surgeon), and a psychiatric evaluation was obtained if considered necessary. All patients completed routine preoperative investigations, including upper gastrointestinal endoscopy, chest radiography, abdominal computed tomography (CT), abdominal ultrasound examination, and nutritional assessment. Preoperative QOL was measured using the Moorhead-Ardelt questionnaire at the same visit.

All patients in this study were operated on by the same surgical team of surgeons with more than 60 LSG experiences.Postoperative treatment was performed based on the patient's condition.

Description

Inclusion Criteria:

  • Obese patients who met the indications for LSG and were followed up regularly as planned after surgery.

Exclusion Criteria:

  1. incomplete critical clinical data;
  2. incomplete imaging data;
  3. insufficient follow-up data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sarcopenic obesity group
Patients who underwent LSG with FM/FFM>0.80 calculated from the cross-sectional CT image of L3 vertebra.
Procedure: Laparoscopic sleeve gastrectomy
Laparoscopic sleeve gastrectomy was performed in all patients with or without SO.
Non-sarcopenic obesity group
Patients who underwent LSG with FM/FFM<0.80 calculated from the cross-sectional CT image of L3 vertebra.
Procedure: Laparoscopic sleeve gastrectomy
Laparoscopic sleeve gastrectomy was performed in all patients with or without SO.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
%EWL
Time Frame: 6 month after surgery
Percentage excess weight loss is calculated as (initial weight - 6-month weight)/(initial weight - ideal weight) × 100%.
6 month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
%EWL
Time Frame: 1 month after surgery
Percentage excess weight loss is calculated as (initial weight - 1-month weight)/(initial weight - ideal weight) × 100%.
1 month after surgery
%EWL
Time Frame: 3 month after surgery
Percentage excess weight loss is calculated as (initial weight - 3-month weight)/(initial weight - ideal weight) × 100%.
3 month after surgery
%EWL
Time Frame: 9 month after surgery
Percentage excess weight loss is calculated as (initial weight - 9-month weight)/(initial weight - ideal weight) × 100%.
9 month after surgery
%EWL
Time Frame: 12 month after surgery
Percentage excess weight loss is calculated as (initial weight - 12-month weight)/(initial weight - ideal weight) × 100%.
12 month after surgery
%TWL
Time Frame: 6 month after surgery
Percentage total weight loss is calculated as (initial weight - 6-month weight)/(initial weight) × 100%
6 month after surgery
%TWL
Time Frame: 12 month after surgery
Percentage total weight loss is calculated as (initial weight - 12-month weight)/(initial weight) × 100%
12 month after surgery
EBMI
Time Frame: 6 month after surgery
Excess BMI is calculated as(follow-up BMI - ideal BMI)
6 month after surgery
%WL
Time Frame: 6 month after surgery
Percentage weight loss is calculated as (follow-up weight/initial weight) × 100%
6 month after surgery
MA II score
Time Frame: 6 month after surgery
Moorhead-Ardelt QOL questionnaire is a six-item self-report questionnaire that assesses the patient's subjective impression of QOL,The total score ranges from -3 to +3 and defines five outcome groups: very poor, poor, fair, good, and very good. Good and very good outcomes were considered satisfactory.
6 month after surgery
BAROS score
Time Frame: 6 month after surgery
The Bariatric Analysis and Reporting Outcome System(BAROS)combines the Moorhead-Ardelt QOL questionnaire with other data relevant to bariatric surgery, including the %EWL, improvement in comorbid conditions, and complications.A BAROS score ≤1 was considered a failure; >1-3, fair; >3-5, good; >5-7, very good; and >7, excellent.
6 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University

Investigators

  • Study Chair: Chang-Ming Huang, Ph.D, Fujian Medical University Union Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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