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Sarcopenic ObesityNCT05826210

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

An observational study of Sarcopenic Obesity and Body Composition, run by Fujian Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 16 to 65 years
Conditions the study is for
Sarcopenic Obesity, Body Composition
What is being tested?
Laparoscopic sleeve gastrectomy
Type of treatment
Surgery or procedure
How many people
245 participants
Where
1 siteChina
Study dates
1 Jan 2015to 31 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Chang-ming Huang

    Fuzhou, Fujian, 350001

Other trials in China

About this study

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.

Being tested
Laparoscopic sleeve gastrectomy
Keywords
laparoscopic sleeve gastrectomy, weight loss, sarcopenic obesity, Fat-free mass, Quality of life
Medical subject headings
Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic sleeve gastrectomyProcedure or surgery

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

Study groups in NCT05826210
Study groupRoleWhat they receive
Sarcopenic obesity groupPatients who underwent LSG with FM/FFM>0.80 calculated from the cross-sectional CT image of L3 vertebra.
Receives: Procedure: Laparoscopic sleeve gastrectomy
Non-sarcopenic obesity groupPatients who underwent LSG with FM/FFM<0.80 calculated from the cross-sectional CT image of L3 vertebra.
Receives: Procedure: Laparoscopic sleeve gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. %EWL

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

    Measured: 6 month after surgery

Secondary outcomes (10)

  1. %EWL

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

    Measured: 1 month after surgery

  2. %EWL

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

    Measured: 3 month after surgery

  3. %EWL

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

    Measured: 9 month after surgery

  4. %EWL

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

    Measured: 12 month after surgery

  5. %TWL

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

    Measured: 6 month after surgery

  6. %TWL

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

    Measured: 12 month after surgery

  7. EBMI

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

    Measured: 6 month after surgery

  8. %WL

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

    Measured: 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.

    Measured: 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.

    Measured: 6 month after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2023
  2. Study start1 Jan 2015
  3. Primary completion1 Jul 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
245 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05826210
Sponsor's protocol ID
2023-03
Status last verified
Apr 2023
First submitted
12 Apr 2023
Last updated
24 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28604169

  • 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.

    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

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcopenic Obesity and Body Composition, run by Fujian Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

%EWL (time frame: 6 month after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05826210, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023.

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