Efficacy of Sodium Glucose Cotransporter 2 Inhibitors on Non-Alcoholic Fatty Liver Disease

NCT06739486 | Not Yet Recruiting

• 1 other identifier: SGLT.2 inhibitors
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

evaluate the effectiveness of sodium-glucose cotransporter-2 (SGLT.2) inhibitors in improving hepatic steatosis and hepatic fibrosis using imaging biomarkers and histopathology in patients with non-alcoholic fatty liver disease

Conditions

Non Alcholic Fatty Liver Disease; Hepatic Steatosis; Hepatic Fibrosis; NAFLD (Nonalcoholic Fatty Liver Disease)

Keywords

NAFLD; Non alcoholic fatty liver disease; Hepatic steatosis; Hepatic fibrosis; Na glucose cotransporter 2 inhibitors; SGLT-2 inhibitors

Outcome Measures

Primary Outcomes (1)

• determine the effects of dapagliflozin, an SGLT2 inhibitor, on hepatic fibrosis and steatosis in patients with NAFLD using fibroscan and biomarkers

  Baseline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients aged over 18 years, not alcohol drinker,has any cause of liver affection,or with kidney function affection

You may qualify if:

• age \>18 years
• both sex

You may not qualify if:

• alcohol drinker
• any cause of liver affection (hepatitis, autoimmune…etc)
• patients with kidney function affection

Sponsors & Collaborators

• Assiut University: lead

Related Publications (13)

• Foucher J, Chanteloup E, Vergniol J, Castera L, Le Bail B, Adhoute X, Bertet J, Couzigou P, de Ledinghen V. Diagnosis of cirrhosis by transient elastography (FibroScan): a prospective study. Gut. 2006 Mar;55(3):403-8. doi: 10.1136/gut.2005.069153. Epub 2005 Jul 14.

  PMID: 16020491 BACKGROUND

• Ge X, Zheng L, Wang M, Du Y, Jiang J. Prevalence trends in non-alcoholic fatty liver disease at the global, regional and national levels, 1990-2017: a population-based observational study. BMJ Open. 2020 Aug 3;10(8):e036663. doi: 10.1136/bmjopen-2019-036663.

  PMID: 32747349 BACKGROUND

• Younossi ZM, Golabi P, de Avila L, Paik JM, Srishord M, Fukui N, Qiu Y, Burns L, Afendy A, Nader F. The global epidemiology of NAFLD and NASH in patients with type 2 diabetes: A systematic review and meta-analysis. J Hepatol. 2019 Oct;71(4):793-801. doi: 10.1016/j.jhep.2019.06.021. Epub 2019 Jul 4.

  PMID: 31279902 BACKGROUND

• Li X, Wang H. Multiple organs involved in the pathogenesis of non-alcoholic fatty liver disease. Cell Biosci. 2020 Dec 7;10(1):140. doi: 10.1186/s13578-020-00507-y.

  PMID: 33372630 BACKGROUND

• Adams LA, Lymp JF, St Sauver J, Sanderson SO, Lindor KD, Feldstein A, Angulo P. The natural history of nonalcoholic fatty liver disease: a population-based cohort study. Gastroenterology. 2005 Jul;129(1):113-21. doi: 10.1053/j.gastro.2005.04.014.

  PMID: 16012941 BACKGROUND

• Soderberg C, Stal P, Askling J, Glaumann H, Lindberg G, Marmur J, Hultcrantz R. Decreased survival of subjects with elevated liver function tests during a 28-year follow-up. Hepatology. 2010 Feb;51(2):595-602. doi: 10.1002/hep.23314.

  PMID: 20014114 BACKGROUND

• Tahara A, Takasu T. SGLT2 inhibitor ipragliflozin alone and combined with pioglitazone prevents progression of nonalcoholic steatohepatitis in a type 2 diabetes rodent model. Physiol Rep. 2019 Nov;7(22):e14286. doi: 10.14814/phy2.14286.

  PMID: 31782258 BACKGROUND

• Wei Q, Xu X, Guo L, Li J, Li L. Effect of SGLT2 Inhibitors on Type 2 Diabetes Mellitus With Non-Alcoholic Fatty Liver Disease: A Meta-Analysis of Randomized Controlled Trials. Front Endocrinol (Lausanne). 2021 Jun 17;12:635556. doi: 10.3389/fendo.2021.635556. eCollection 2021.

  PMID: 34220701 BACKGROUND

• Jojima T, Tomotsune T, Iijima T, Akimoto K, Suzuki K, Aso Y. Empagliflozin (an SGLT2 inhibitor), alone or in combination with linagliptin (a DPP-4 inhibitor), prevents steatohepatitis in a novel mouse model of non-alcoholic steatohepatitis and diabetes. Diabetol Metab Syndr. 2016 Jul 26;8:45. doi: 10.1186/s13098-016-0169-x. eCollection 2016.

  PMID: 27462372 BACKGROUND

• Arai T, Atsukawa M, Tsubota A, Mikami S, Ono H, Kawano T, Yoshida Y, Tanabe T, Okubo T, Hayama K, Nakagawa-Iwashita A, Itokawa N, Kondo C, Kaneko K, Emoto N, Nagao M, Inagaki K, Fukuda I, Sugihara H, Iwakiri K. Effect of sodium-glucose cotransporter 2 inhibitor in patients with non-alcoholic fatty liver disease and type 2 diabetes mellitus: a propensity score-matched analysis of real-world data. Ther Adv Endocrinol Metab. 2021 Mar 21;12:20420188211000243. doi: 10.1177/20420188211000243. eCollection 2021.

  PMID: 33815743 BACKGROUND

• Shimizu M, Suzuki K, Kato K, Jojima T, Iijima T, Murohisa T, Iijima M, Takekawa H, Usui I, Hiraishi H, Aso Y. Evaluation of the effects of dapagliflozin, a sodium-glucose co-transporter-2 inhibitor, on hepatic steatosis and fibrosis using transient elastography in patients with type 2 diabetes and non-alcoholic fatty liver disease. Diabetes Obes Metab. 2019 Feb;21(2):285-292. doi: 10.1111/dom.13520. Epub 2018 Oct 2.

  PMID: 30178600 BACKGROUND

• Adams LA, Anstee QM, Tilg H, Targher G. Non-alcoholic fatty liver disease and its relationship with cardiovascular disease and other extrahepatic diseases. Gut. 2017 Jun;66(6):1138-1153. doi: 10.1136/gutjnl-2017-313884. Epub 2017 Mar 17.

  PMID: 28314735 BACKGROUND

• Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.

  PMID: 26707365 BACKGROUND

MeSH Terms

Conditions

Fatty Liver; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Abdallah A Gamal, Resident

  Assiut University

  PRINCIPAL INVESTIGATOR

• Lobna A Farag, Lecturer

  Assiut University

  STUDY DIRECTOR

• Mohamed A Abozaid, Lecturer

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Abdallah A Gamal, Resident

CONTACT

01153381807; drboudy81@gmail.com

Lobna A Farag, Lecturer

CONTACT

01005571004; leltoni@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal resident

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: December 18, 2024
• Study Start: December 20, 2024
• Primary Completion: November 20, 2025
• Study Completion: December 20, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-11