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CompletedNCT05826210Updated Apr 24, 2023

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

An observational study in Sarcopenic Obesity and Body Composition, sponsored by Fujian Medical University. Completed at 1 site in China. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-04-24.

Sponsored by Fujian Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
245
Ages
16 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Sarcopenic Obesity
  • Body Composition

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Keywords

  • laparoscopic sleeve gastrectomy
  • weight loss
  • sarcopenic obesity
  • Fat-free mass
  • Quality of life
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 245 is above the median of 135 across 1,283 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Fujian Medical University is the lead sponsor of 144 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
245 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • ProcedureLaparoscopic sleeve gastrectomy

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

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What researchers measure

Primary outcomes

  1. %EWL

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

    Time frame: 6 month after surgery

Secondary outcomes

  1. %EWL

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

    Time frame: 1 month after surgery

  2. %EWL

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

    Time frame: 3 month after surgery

  3. %EWL

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

    Time frame: 9 month after surgery

  4. %EWL

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

    Time frame: 12 month after surgery

  5. %TWL

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

    Time frame: 6 month after surgery

  6. %TWL

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

    Time frame: 12 month after surgery

  7. EBMI

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

    Time frame: 6 month after surgery

  8. %WL

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

    Time frame: 6 month after surgery

  9. MA II score

    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.

    Time frame: 6 month after surgery

  10. BAROS score

    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.

    Time frame: 6 month after surgery

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Study locations

1 site
  • Chang-ming Huang
    Fuzhou, Fujian 350001, China
08

References and documents

Publications

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  • Sung H, Siegel RL, Torre LA, Pearson-Stuttard J, Islami F, Fedewa SA, Goding Sauer A, Shuval K, Gapstur SM, Jacobs EJ, Giovannucci EL, Jemal A. Global patterns in excess body weight and the associated cancer burden. CA Cancer J Clin. 2019 Mar;69(2):88-112. doi: 10.3322/caac.21499. Epub 2018 Dec 12. PubMed 30548482 ↗
  • Panagiotou OA, Markozannes G, Adam GP, Kowalski R, Gazula A, Di M, Bond DS, Ryder BA, Trikalinos TA. Comparative Effectiveness and Safety of Bariatric Procedures in Medicare-Eligible Patients: A Systematic Review. JAMA Surg. 2018 Nov 1;153(11):e183326. doi: 10.1001/jamasurg.2018.3326. Epub 2018 Nov 21. PubMed 30193303 ↗
  • Thibault R, Genton L, Pichard C. Body composition: why, when and for who? Clin Nutr. 2012 Aug;31(4):435-47. doi: 10.1016/j.clnu.2011.12.011. Epub 2012 Jan 31. PubMed 22296871 ↗
  • Prado CM, Wells JC, Smith SR, Stephan BC, Siervo M. Sarcopenic obesity: A Critical appraisal of the current evidence. Clin Nutr. 2012 Oct;31(5):583-601. doi: 10.1016/j.clnu.2012.06.010. Epub 2012 Jul 17. PubMed 22809635 ↗
  • Kim TN, Choi KM. Sarcopenia: definition, epidemiology, and pathophysiology. J Bone Metab. 2013 May;20(1):1-10. doi: 10.11005/jbm.2013.20.1.1. Epub 2013 May 13. PubMed 24524049 ↗
  • Dhana K, Koolhaas CM, Schoufour JD, Rivadeneira F, Hofman A, Kavousi M, Franco OH. Association of anthropometric measures with fat and fat-free mass in the elderly: The Rotterdam study. Maturitas. 2016 Jun;88:96-100. doi: 10.1016/j.maturitas.2016.03.018. Epub 2016 Apr 1. Erratum In: Maturitas. 2017 Jun;100:92. doi: 10.1016/j.maturitas.2017.02.001. PubMed 27105706 ↗
  • Low S, Goh KS, Ng TP, Ang SF, Moh A, Wang J, Ang K, Subramaniam T, Sum CF, Lim SC. The prevalence of sarcopenic obesity and its association with cognitive performance in type 2 diabetes in Singapore. Clin Nutr. 2020 Jul;39(7):2274-2281. doi: 10.1016/j.clnu.2019.10.019. Epub 2019 Nov 4. PubMed 31744622 ↗
  • Baracos VE, Arribas L. Sarcopenic obesity: hidden muscle wasting and its impact for survival and complications of cancer therapy. Ann Oncol. 2018 Feb 1;29(suppl_2):ii1-ii9. doi: 10.1093/annonc/mdx810. PubMed 29506228 ↗
  • Hong SH, Choi KM. Sarcopenic Obesity, Insulin Resistance, and Their Implications in Cardiovascular and Metabolic Consequences. Int J Mol Sci. 2020 Jan 13;21(2):494. doi: 10.3390/ijms21020494. PubMed 31941015 ↗
  • Huang R, Gagner M. A Thickness Calibration Device Is Needed to Determine Staple Height and Avoid Leaks in Laparoscopic Sleeve Gastrectomy. Obes Surg. 2015 Dec;25(12):2360-7. doi: 10.1007/s11695-015-1705-8. PubMed 26024735 ↗
  • Xu G, Song M. Recent advances in the mechanisms underlying the beneficial effects of bariatric and metabolic surgery. Surg Obes Relat Dis. 2021 Jan;17(1):231-238. doi: 10.1016/j.soard.2020.08.028. Epub 2020 Aug 31. PubMed 33036939 ↗
  • Manoy P, Anomasiri W, Yuktanandana P, Tanavalee A, Ngarmukos S, Tanpowpong T, Honsawek S. Elevated serum leptin levels are associated with low vitamin D, sarcopenic obesity, poor muscle strength, and physical performance in knee osteoarthritis. Biomarkers. 2017 Dec;22(8):723-730. doi: 10.1080/1354750X.2017.1315615. Epub 2017 Apr 19. PubMed 28374624 ↗
  • Shetty GK, Matarese G, Magkos F, Moon HS, Liu X, Brennan AM, Mylvaganam G, Sykoutri D, Depaoli AM, Mantzoros CS. Leptin administration to overweight and obese subjects for 6 months increases free leptin concentrations but does not alter circulating hormones of the thyroid and IGF axes during weight loss induced by a mild hypocaloric diet. Eur J Endocrinol. 2011 Aug;165(2):249-54. doi: 10.1530/EJE-11-0252. Epub 2011 May 20. PubMed 21602313 ↗
  • Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2. PubMed 2070995 ↗
  • Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. PubMed 15273542 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05826210
Lead sponsor
Fujian Medical University
Responsible party
Chang-Ming Huang, Prof. (Prof., Fujian Medical University Union Hospital) — Principal investigator
First posted
Apr 24, 2023
Start date
Jan 1, 2015
Primary completion
Jul 1, 2022
Completion
Dec 31, 2022
Last update
Apr 24, 2023

Study contacts

Chang-Ming Huang, Ph.D
study chair · Fujian Medical University Union Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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