NCT05826210

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

7.5 years

First QC Date

April 12, 2023

Last Update Submit

April 12, 2023

Conditions

Keywords

laparoscopic sleeve gastrectomyweight losssarcopenic obesityFat-free massQuality of life

Outcome Measures

Primary Outcomes (1)

  • %EWL

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

    6 month after surgery

Secondary Outcomes (10)

  • %EWL

    1 month after surgery

  • %EWL

    3 month after surgery

  • %EWL

    9 month after surgery

  • %EWL

    12 month after surgery

  • %TWL

    6 month after surgery

  • +5 more secondary outcomes

Study Arms (2)

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

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

Non-sarcopenic obesity groupSarcopenic obesity group

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang-ming Huang

Fuzhou, Fujian, 350001, China

Location

Related Publications (16)

  • GBD 2015 Obesity Collaborators; Afshin A, Forouzanfar MH, Reitsma MB, Sur P, Estep K, Lee A, Marczak L, Mokdad AH, Moradi-Lakeh M, Naghavi M, Salama JS, Vos T, Abate KH, Abbafati C, Ahmed MB, Al-Aly Z, Alkerwi A, Al-Raddadi R, Amare AT, Amberbir A, Amegah AK, Amini E, Amrock SM, Anjana RM, Arnlov J, Asayesh H, Banerjee A, Barac A, Baye E, Bennett DA, Beyene AS, Biadgilign S, Biryukov S, Bjertness E, Boneya DJ, Campos-Nonato I, Carrero JJ, Cecilio P, Cercy K, Ciobanu LG, Cornaby L, Damtew SA, Dandona L, Dandona R, Dharmaratne SD, Duncan BB, Eshrati B, Esteghamati A, Feigin VL, Fernandes JC, Furst T, Gebrehiwot TT, Gold A, Gona PN, Goto A, Habtewold TD, Hadush KT, Hafezi-Nejad N, Hay SI, Horino M, Islami F, Kamal R, Kasaeian A, Katikireddi SV, Kengne AP, Kesavachandran CN, Khader YS, Khang YH, Khubchandani J, Kim D, Kim YJ, Kinfu Y, Kosen S, Ku T, Defo BK, Kumar GA, Larson HJ, Leinsalu M, Liang X, Lim SS, Liu P, Lopez AD, Lozano R, Majeed A, Malekzadeh R, Malta DC, Mazidi M, McAlinden C, McGarvey ST, Mengistu DT, Mensah GA, Mensink GBM, Mezgebe HB, Mirrakhimov EM, Mueller UO, Noubiap JJ, Obermeyer CM, Ogbo FA, Owolabi MO, Patton GC, Pourmalek F, Qorbani M, Rafay A, Rai RK, Ranabhat CL, Reinig N, Safiri S, Salomon JA, Sanabria JR, Santos IS, Sartorius B, Sawhney M, Schmidhuber J, Schutte AE, Schmidt MI, Sepanlou SG, Shamsizadeh M, Sheikhbahaei S, Shin MJ, Shiri R, Shiue I, Roba HS, Silva DAS, Silverberg JI, Singh JA, Stranges S, Swaminathan S, Tabares-Seisdedos R, Tadese F, Tedla BA, Tegegne BS, Terkawi AS, Thakur JS, Tonelli M, Topor-Madry R, Tyrovolas S, Ukwaja KN, Uthman OA, Vaezghasemi M, Vasankari T, Vlassov VV, Vollset SE, Weiderpass E, Werdecker A, Wesana J, Westerman R, Yano Y, Yonemoto N, Yonga G, Zaidi Z, Zenebe ZM, Zipkin B, Murray CJL. Health Effects of Overweight and Obesity in 195 Countries over 25 Years. N Engl J Med. 2017 Jul 6;377(1):13-27. doi: 10.1056/NEJMoa1614362. Epub 2017 Jun 12.

    PMID: 28604169BACKGROUND
  • 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.

    PMID: 30548482BACKGROUND
  • 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.

    PMID: 30193303BACKGROUND
  • 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.

    PMID: 22296871BACKGROUND
  • 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.

    PMID: 22809635BACKGROUND
  • 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.

    PMID: 24524049BACKGROUND
  • 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.

    PMID: 27105706BACKGROUND
  • 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.

    PMID: 31744622BACKGROUND
  • 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.

    PMID: 29506228BACKGROUND
  • 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.

    PMID: 31941015BACKGROUND
  • 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.

    PMID: 26024735BACKGROUND
  • 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.

    PMID: 33036939BACKGROUND
  • 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.

    PMID: 28374624BACKGROUND
  • 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.

    PMID: 21602313BACKGROUND
  • 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.

    PMID: 2070995BACKGROUND
  • 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.

    PMID: 15273542BACKGROUND

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chang-Ming Huang, Ph.D

    Fujian Medical University Union Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

April 12, 2023

First Posted

April 24, 2023

Study Start

January 1, 2015

Primary Completion

July 1, 2022

Study Completion

December 31, 2022

Last Updated

April 24, 2023

Record last verified: 2023-04

Locations