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Completed

NCT Number: NCT05826210

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

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.

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Key information

Conditions

Sarcopenic Obesity Body Composition Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang-ming Huang

Fuzhou, Fujian, 350001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • incomplete critical clinical data;
  • incomplete imaging data;
  • insufficient follow-up data.

Treatment and study plan

Laparoscopic sleeve gastrectomy

Procedure

Laparoscopic sleeve gastrectomy was performed in all patients with or without SO.

Primary outcomes

  1. %EWL

    Time frame: 6 month after surgery

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

Secondary outcomes

  1. %EWL

    Time frame: 1 month after surgery

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

  2. %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. %EWL

    Time frame: 9 month after surgery

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

  4. %EWL

    Time frame: 12 month after surgery

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

  5. %TWL

    Time frame: 6 month after surgery

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

  6. %TWL

    Time frame: 12 month after surgery

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

  7. EBMI

    Time frame: 6 month after surgery

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

  8. %WL

    Time frame: 6 month after surgery

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

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Apr 24, 2023
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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