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

Sponsor
Fujian Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT05826210
Collaborator
(none)
245
Enrollment
1
Location
96
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Laparoscopic sleeve gastrectomy

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 Design

Study Type:
Observational
Actual Enrollment :
245 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Jul 1, 2022
Actual Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. %EWL [6 month after surgery]

    Percentage excess weight loss is calculated as (initial weight - 6-month weight)/(initial weight - ideal weight) × 100%.

Secondary Outcome Measures

  1. %EWL [1 month after surgery]

    Percentage excess weight loss is calculated as (initial weight - 1-month weight)/(initial weight - ideal weight) × 100%.

  2. %EWL [3 month after surgery]

    Percentage excess weight loss is calculated as (initial weight - 3-month weight)/(initial weight - ideal weight) × 100%.

  3. %EWL [9 month after surgery]

    Percentage excess weight loss is calculated as (initial weight - 9-month weight)/(initial weight - ideal weight) × 100%.

  4. %EWL [12 month after surgery]

    Percentage excess weight loss is calculated as (initial weight - 12-month weight)/(initial weight - ideal weight) × 100%.

  5. %TWL [6 month after surgery]

    Percentage total weight loss is calculated as (initial weight - 6-month weight)/(initial weight) × 100%

  6. %TWL [12 month after surgery]

    Percentage total weight loss is calculated as (initial weight - 12-month weight)/(initial weight) × 100%

  7. EBMI [6 month after surgery]

    Excess BMI is calculated as(follow-up BMI - ideal BMI)

  8. %WL [6 month after surgery]

    Percentage weight loss is calculated as (follow-up weight/initial weight) × 100%

  9. MA II score [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.

  10. BAROS score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chang-ming Huang Fuzhou Fujian China 350001

Sponsors and Collaborators

  • Fujian Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Chang-Ming Huang, Prof., Prof., Fujian Medical University Union Hospital
ClinicalTrials.gov Identifier:
NCT05826210
Other Study ID Numbers:
  • 2023-03
First Posted:
Apr 24, 2023
Last Update Posted:
Apr 24, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chang-Ming Huang, Prof., Prof., Fujian Medical University Union Hospital
laparoscopic sleeve gastrectomy
weight loss
sarcopenic obesity
Fat-free mass
Quality of life
Additional relevant MeSH terms:
Obesity

Study Results

No Results Posted as of Apr 24, 2023