Short Term Outcome of Metabolic Associated Fatty Liver Disease (MAFLD) in Patients Undergoing Bariatric Surgery

NCT06180928 | Unknown

• 1 other identifier: MAFLD and bariatric surgery
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Obesity has become one of the most critical public health problems in economically developed and developing countries in the world. Bariatric surgery is an option for obese individuals who fail to achieve suitable weight loss with lifestyle changes and pharmacological methods. Bariatric surgery can help obese individuals achieve recommended weight reduction and thus improve the course of MAFLD. The additional benefits of bariatric surgery include resolution or amelioration of hypertension, hyperlipidemia and type 2 diabetes and reduction of cardiovascular risk and mortality . The relation between rate of weight loss after bariatric surgeries and the course of the MAFLD not well studied befor ,So we are aiming to assess the outcome of MAFLD ,TSH in patients undergoing Barietric surgeries and if there is significant correlation of steatosis and rate of weight loss among those patients.

Conditions

Metabolic Associated Fatty Liver Disease; Bariatric Surgery Candidate

Keywords

MAFLD

Outcome Measures

Primary Outcomes (2)

• Assess the effect of bariatric surgery in the course of hepatic steatosis among MAFLD patients.

  fiboscan as A CAP score that falls anywhere between 238 to 260 dB/m represents 11-33% fatty change in the liver. A CAP score that falls anywhere between 260 to 290 dB/m represents 34-66% fatty change in the liver. A CAP score that is 290 dB/m or higher represents over 67% fatty change in the liver

  baseline

• studying effect of weight reduction at the level of TSH

  Measure the level TSH (mIU/L) in patienta befor and after bariatric surgery incorrolation on weight loss (kg)

  baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients more than 18 years old and diagnosed with metabolic associated fatty liver disease and planning to undergo bariatric surgery

You may qualify if:

• Patients more than 18 years old and diagnosed with metabolic associated fatty liver disease and planning to undergo bariatric surgery

You may not qualify if:

• Age below 18 years old.
• Patients have history of HBV...HCV
• patients with autoimmune hepatitis
• Alcoholic patients
• Drug induced hepatitis
• Willson Diseaese
• Haemochromatosis Diseaese

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• Lin X, Li H. Obesity: Epidemiology, Pathophysiology, and Therapeutics. Front Endocrinol (Lausanne). 2021 Sep 6;12:706978. doi: 10.3389/fendo.2021.706978. eCollection 2021.

  PMID: 34552557 RESULT

• Le MH, Yeo YH, Zou B, Barnet S, Henry L, Cheung R, Nguyen MH. Forecasted 2040 global prevalence of nonalcoholic fatty liver disease using hierarchical bayesian approach. Clin Mol Hepatol. 2022 Oct;28(4):841-850. doi: 10.3350/cmh.2022.0239. Epub 2022 Sep 19.

  PMID: 36117442 RESULT

• Eslam M, Sanyal AJ, George J; International Consensus Panel. MAFLD: A Consensus-Driven Proposed Nomenclature for Metabolic Associated Fatty Liver Disease. Gastroenterology. 2020 May;158(7):1999-2014.e1. doi: 10.1053/j.gastro.2019.11.312. Epub 2020 Feb 8.

  PMID: 32044314 RESULT

• Kamal MEEM, Aisha HAA, Fahmy MH, Abosayed AK. The Impact of Laparoscopic Sleeve Gastrectomy on Thyroid Functions in Egyptian Patients with Obesity. J Gastrointest Surg. 2023 Jul;27(7):1345-1352. doi: 10.1007/s11605-023-05662-4. Epub 2023 Apr 5.

  PMID: 37020159 RESULT

• Diemieszczyk I, Wozniewska P, Golaszewski P, Drygalski K, Nadolny K, Ladny JR, Razak Hady H. Does weight loss after laparoscopic sleeve gastrectomy contribute to reduction in blood pressure? Pol Arch Intern Med. 2021 Aug 30;131(7-8):693-700. doi: 10.20452/pamw.16023. Epub 2021 Jun 2.

  PMID: 34075736 RESULT

• Nannipieri M, Cecchetti F, Anselmino M, Mancini E, Marchetti G, Bonotti A, Baldi S, Solito B, Giannetti M, Pinchera A, Santini F, Ferrannini E. Pattern of expression of adiponectin receptors in human liver and its relation to nonalcoholic steatohepatitis. Obes Surg. 2009 Apr;19(4):467-74. doi: 10.1007/s11695-008-9701-x. Epub 2008 Oct 16.

  PMID: 18923878 RESULT

• Lassailly G, Caiazzo R, Buob D, Pigeyre M, Verkindt H, Labreuche J, Raverdy V, Leteurtre E, Dharancy S, Louvet A, Romon M, Duhamel A, Pattou F, Mathurin P. Bariatric Surgery Reduces Features of Nonalcoholic Steatohepatitis in Morbidly Obese Patients. Gastroenterology. 2015 Aug;149(2):379-88; quiz e15-6. doi: 10.1053/j.gastro.2015.04.014. Epub 2015 Apr 25.

  PMID: 25917783 RESULT

• Pasquali R, Casanueva F, Haluzik M, van Hulsteijn L, Ledoux S, Monteiro MP, Salvador J, Santini F, Toplak H, Dekkers OM. European Society of Endocrinology Clinical Practice Guideline: Endocrine work-up in obesity. Eur J Endocrinol. 2020 Jan;182(1):G1-G32. doi: 10.1530/EJE-19-0893.

  PMID: 31855556 RESULT

Study Officials

• Zeinelabdeen Ahmed Sayed, Professor

  Assiut University

  STUDY CHAIR

• Ghada AbdelRahman, professor

  Assiut University

  STUDY DIRECTOR

• bahaa osman, lecturer

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Essam Mohie Atef Sayed, Dr

CONTACT

+201015391514; essam.mohie3@gmail.com

Hager Khedr, Dr

CONTACT

+201002983656; hagerkhedr445@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: priniciple investigator

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: December 26, 2023
• Study Start: January 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 26, 2023

Record last verified: 2023-12