Effect of Sodium Glucose Cotransporter Inhibitors Fatty Liver Disease Patients Fatigue Assessment

NCT05694923 | Completed DMC

• 1 other identifier: Assiut 1989
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief Summary

Non-alcoholic fatty liver disease (NAFLD) has become a major health problem worldwide with an increasing prevalence ranging from 13% in Africa to 42% in South-East Asia. The term NAFLD includes a variety of diseases, ranging from liver fat deposition in more than 5% of hepatocytes (steatosis-non-alcoholic fatty liver (NAFL)) to necroinflammation and fibrosis (non-alcoholic steatohepatitis (NASH)), which can progress into NASH-cirrhosis, and eventually to hepatocellular carcinoma 1 Lifestyle modifications remain the cornerstone of NAFLD treatment, even though various pharmaceutical interventions are currently under clinical trial. Among them, sodium-glucose co-transporter type-2 inhibitors (SGLT-2i) are emerging as promising agents. Processes regulated by SGLT-2i, such as endoplasmic reticulum (ER) and oxidative stress, low-grade inflammation, autophagy and apoptosis are all implicated in NAFLD pathogenesis 2 In non-DM patients, only a small single center study exists which studied 12 patients under dapagliflozin and 10 patients under teneligliptin, a DPP4 inhibitor, for a total of 12 weeks, showing that after this intervention period, serum transaminases were decreased in both groups, while in the dapagliflozin group, total body water and body fat decreased, leading to decreased total body weight.3

Conditions

Fatty Liver Disease

Keywords

Fatty Liver Nonalcoholic nondiabetic

Outcome Measures

Primary Outcomes (1)

• To evaluate efficacy of sodium glucose cotransporter inhibitors to reduce hepatic steatosis and fibrosis among non diabetic non alcoholic fatty liver patients

  assessment of fibrosis and steatosis by 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

  3 MONTHS

Secondary Outcomes (1)

• fatigue assessment

  6 month

Study Arms (2)

life style modification and diet control

NO INTERVENTION

33 patient of non alcoholic fatty liver patients and non diabetic only receive life style modification and diet control

empaglifizon 10 mg plus life style and diet control

EXPERIMENTAL

22 patient of non alcoholic fatty liver patients and non diabetic Will receive empaglifizon in minimum dose 10 mg in addition to life style modification and diet control

Drug: Empagliflozin 10 MG

Interventions

Empagliflozin 10 MG DRUG

non fatty liver non alcoholic patients Will receive empaglifizon sodium glucose cotransporter in minimum dose 10 mg

empaglifizon 10 mg plus life style and diet control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non alcoholic fatty liver patients diagnosed at outpatient clinic of Assiut university

You may not qualify if:

• \- DM Patient Patient with viral hepatitis C,B Patient with hypothyroidism Patient with hepatotoxic drugs

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Faculty of Medicine

Asyut, 71515, Egypt

Location

Bahaa Osman

Asyut, Egypt

Location

Related Publications (1)

• Taha BO, Kobeisy MA, Abdelmohsen E, Abdelrhman T, Abokresha MM, Hassanein ZM, AbdEllah-Alawi MHM. Outcomes of empagliflozin in nondiabetic fatty liver patients: A randomized controlled trial. J Taibah Univ Med Sci. 2025 Aug 7;20(4):525-532. doi: 10.1016/j.jtumed.2025.07.008. eCollection 2025 Aug.

  PMID: 40823521 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• bahaa osman taha

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of internal medicine

Model Details: Single center clinical randomized trial open labelled study patients of non diabetic non alcoholic fatty liver from outpatient clinic at assiut university will be randomized and recruited into arms Group A Will receive empaglifizon sodium glucose cotransporter in minimum dose 10 mg Group B Will be Instructed for diet control

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 23, 2023
• Study Start: April 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: April 1, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

EG (2)