Comparative Clinical Study Between Empagliflozin Versus Pioglitazone in Non-diabetic Patients With Non-alcoholic Steatohepatitis
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ClinicalTrials.gov Identifier: NCT05605158 |
Recruitment Status :
Not yet recruiting
First Posted : November 4, 2022
Last Update Posted : November 4, 2022
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This study aims to evaluate the possible beneficial effect of empagliflozin versus pioglitazone on non-diabetic patients with non-alcoholic steatohepatitis (NASH).
This study will be a randomized, comparative parallel study. The study will be conducted according to the ethical standards of Helsinki declaration in 1964 and its later amendments.
The study duration will be 24 weeks. The patients will be randomized into two groups:
Group 1: (Pioglitazone group; n=28) which will receive 30mg/day pioglitazone for 24 weeks.
Group 2: (Empagliflozin group; n=28) which will receive 10mg/day empagliflozin for 24 weeks.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non Alcoholic Steatohepatitis | Drug: Pioglitazone 30mg Drug: Empagliflozin 10 MG | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 56 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparative Clinical Study to Evaluate the Possible Beneficial Effect of Empagliflozin Versus Pioglitazone on Non-diabetic Patients With Non-Alcoholic Steatohepatitis |
Estimated Study Start Date : | November 2022 |
Estimated Primary Completion Date : | May 2023 |
Estimated Study Completion Date : | November 2024 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Group 1 (Pioglitazone group; n=28)
Non-diabetic patients with non-alcoholic steatohepatitis will receive 30mg/day pioglitazone for 24 weeks.
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Drug: Pioglitazone 30mg
Pioglitazone 30 mg will be administered orally once daily for 24 weeks. |
Active Comparator: Group 2 (Empagliflozin group; n=28)
Non-diabetic patients with non-alcoholic steatohepatitis will receive 10mg/day empagliflozin for 24 weeks.
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Drug: Empagliflozin 10 MG
Empagliflozin 10 mg will be administered orally once daily for 24 weeks. |
- Change in fibrosis index based on the 4 factors (FIB-4) [ Time Frame: Baseline and 24th week ]FIB-4 will be calculated using the formula: FIB-4 = Age (years)× AST (IU/L)/[platelet count (109/L) × ALT1/2 (IU/L)].
- Change in aspartate transaminase-to-platelet ratio index (APRI) [ Time Frame: Baseline and 24th week ]APRI will be calculated using the formula: APRI = (AST (IU/L)/upper limit of normal AST range) X 100 /platelet count (109/L).
- Change in liver enzymes [ Time Frame: Baseline, 12th and 24th week ]Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and Gamma-glutamyl transferase (GGT) will be determined by kinetic method.
- Cytokeratin-18 (CK-18) [ Time Frame: Baseline and 24th week ]Serum level of cytokeratin-18 (CK-18) will be determined by Enzyme-linked Immunosorbent assay kits.
- Malondialdehyde (MDA) [ Time Frame: Baseline and 24th week ]Serum level of Malondialdehyde (MDA) will be assessed by colorimetric method.
- Tumor necrosis factor-alpha (TNF-α) [ Time Frame: Baseline and 24th week ]Serum levels of Tumor necrosis factor-alpha (TNF-α) will be determined by Enzyme-linked Immunosorbent assay kits.
- Transforming growth factor-beta1 (TGF-β1) [ Time Frame: Baseline and 24th week ]Serum levels of Transforming growth factor-beta1 (TGF-β1) will be determined by Enzyme-linked Immunosrbent assay kits.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Non-diabetic patients.
- Both males and females.
- Age >18 years old.
- Patient with body mass index (BMI) > 30 kg/m2.
- Patients with established diagnosis of NASH based on liver ultrasonography, mild to moderate elevation in aminotransferase activities (>2 but <5 times upper limit of normal), hepatic steatosis index (HSI) >36, and HAIR score of 2 or 3.
Exclusion Criteria:
- Patients with BMI > 40 kg/m2.
- Patients with type 2 diabetes mellitus (T2DM) on the basis of a fasting plasma glucose (FPG) level ≥ 126 mg/dl (7mmol/L) or glycated hemoglobin (HbA1c) > 6.5% (48 mmol/mol).
- Alcohol consumption greater than 20 g per day for women or greater than 30 g for men for at least three consecutive months over the past 5 years.
- History of viral hepatitis, hemochromatosis, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, biliary obstruction, alpha-1 antitrypsin deficiency.
- Patients on medications interfere with lipid and carbohydrate metabolisms.
- Patients with heart failure (New York Heart Association (NYHA) class 2-4).
- Patients with history of cardiovascular events within the past 3 months.
- Patients with renal impairment (eGFR> 45 mL/min/ 1.73 m2).
- Patients with cancer or with a history of cancer treatment over the past 2 years.
- Patients with thyroid disorder.
- Patients on medications associated with steatosis such as Non-steroidal anti-inflammatory drugs (NSAIDs), amiodarone, tamoxifen, estrogen, sodium valproate, corticosteroids, and methotrexate.
- Patients with inflammatory diseases.
- Patients on supplements known to have antioxidant activity such as vitamin E, vitamin C, zinc, and selenium.
- Pregnant and breastfeeding women.
- Females on oral contraceptive pills will be also excluded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05605158
Contact: Aya El-nawasany, Bachelor Degree | 00201110963270 | ynawasany53@gmail.com |
Egypt | |
Tanta University | |
Tanta, Gharbiya, Egypt, 31511 | |
Contact: Aya El-nawasany, Bachelor Degree 00201110963270 ynawasany53@gmail.com |
Responsible Party: | Aya Khaled Mohammed Elnawasany, Principal Investigator, Tanta University |
ClinicalTrials.gov Identifier: | NCT05605158 |
Other Study ID Numbers: |
35937/10/22 |
First Posted: | November 4, 2022 Key Record Dates |
Last Update Posted: | November 4, 2022 |
Last Verified: | November 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
NASH Nonalcoholic fatty liver disease (NAFLD) SGLT2i Empagliflozin Pioglitazone Hepatic steatosis index (HSI) |
Fibrosis index based on the 4 factors (FIB-4) Aspartate transaminase-to-platelet ratio index (APRI) Cytokeratin-18 Transforming growth factor-beta1 (TGF-β1) Malondialdehyde (MDA) |
Fatty Liver Non-alcoholic Fatty Liver Disease Liver Diseases Digestive System Diseases Pioglitazone |
Empagliflozin Hypoglycemic Agents Physiological Effects of Drugs Sodium-Glucose Transporter 2 Inhibitors Molecular Mechanisms of Pharmacological Action |