Evaluating the Efficacy and Safety of Roflumilast in Patients with NASH
- Conditions
- Non-Alcoholic Steatohepatitis (NASH)
- Interventions
- Drug: Vitamin E capsule
- Registration Number
- NCT06677788
- Lead Sponsor
- Tanta University
- Brief Summary
Study type :clinical trial Main purpose :esnsure safety and efficacy of Roflumilast to treat patients with Non-Alcoholic Steatohepatitis Background and aim: Non-alcoholic fatty liver disease is the most prevalent chronic liver disease globally. There is no defined therapy for non-alcholic steatohepatitis (NASH), therefore this study aimed at evaluating the efficacy and safety of Roflumilast in patients with non-alcoholic NASH.
Methods: This randomized controlled parallel study involved 55 patients with NASH who were randomized into vitamin E group or control group (n=24) which received vitamin E 1000 mg once daily and roflumilast group (n=31) which received roflumilast 500 μg once daily for three months.
Patients were assessed at baseline and after intervention through liver stiffness measurement (LSM) using fibro-scan and through evaluation of serum levels of tumor necrosis factor -alpha (TNF-α), Malondialdehyde (MDA), transforming growth factor-beta 1 (TGF-ß1). In addition, liver enzymes, lipid panel, fasting blood glucose and fasting insulin level with subsequent calculation of the homeostatic model assessment for Insulin resistance (HOMA-IR) were also assessed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
- Patients with Cytokeratine level >240 IU/L.
- Adult patient (age > 18 years old).
- Both sex.
- Overweight and obese.
- Patients with evidence of steatosis through imaging.
- Patient with mild to moderate elevation in aminotransferase activity (>2 ,but <5 times upper limit of normal ).
- Patient with Hepatic steatosis index (HSI) > 36.
- Patient with HAIR ( hypertension ,alanine aminotransferase level ,insulin resistance ) of 2 or 3.
- Fibroscan score >7Kpa and < 12.5 Kpa (F2 - F3).
- Alcohol consumer and smokers
- Patients with Wilson's disease and hemochromatosis .
- Patients with viral hepatitis.
- Patients with cirrhosis .
- Patients with inflammatory diseases .
- Patients with other comorbid disease that elevate transaminases (congestive heart failure and malignancy).
- Patients on medications that interfere with lipid and carbohydrate metabolism..
- Patients on stateogenic medications.
- Pregnancy and lactating women.
- Females on oral contraceptive pills.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Roflumilast group (n=31) Roflumilast 500 Mcg Oral Tablet Arm Description: Roflumilast group (n=31) which received roflumilast 500 μg once daily for three months. Patients were assessed at baseline and after intervention through liver stiffness measurement (LSM) using fibro-scan and through evaluation of serum levels of tumor necrosis factor -alpha (TNF-α), Malondialdehyde (MDA), transforming growth factor-beta 1 (TGF-ß1). In addition, liver enzymes, lipid panel, fasting blood glucose and fasting insulin level with subsequent calculation of homeostatic model assessment for Insulin resistance (HOMA-IR) were also assessed. Vitamin E group or control group (n=24) Vitamin E capsule vitamin E group or control group (n=24) which received vitamin E 1000 mg once daily. Patients were assessed at baseline and after intervention through liver stiffness measurement (LSM) using fibro-scan and through evaluation of serum levels of tumor necrosis factor -alpha (TNF-α), Malondialdehyde (MDA), transforming growth factor-beta 1 (TGF-ß1). In addition, liver enzymes, lipid panel, fasting blood glucose and fasting insulin level with subsequent calculation of homeostatic model assessment for Insulin resistance (HOMA-IR) were also assessed.
- Primary Outcome Measures
Name Time Method Change in liver stiffness measurement (LSM) measured by fibroscan score 12 weeks following the end of treatment Liver Stiffness measurement (LSM) by fibro-scan. Transient elastography (Fibroscan, Echosens, Paris) was used to assess liver stiffness depending up-on the method formerly prescribed .Through a single independent operator, at least ten valid measurements were obtained for each patient. Results were included in the final analysis only if the following three criteria were met: at least ten valid measurements, success rate \>60% and the interquartile range (IQR)-to-liver stiffness ratio was ≤0.30. The median values of the validated measurements for each patient were representative to the liver stiffness and expressed in units of kilopascals (kPa)
- Secondary Outcome Measures
Name Time Method The change in liver panel parameters 3 months after treatment Blood sample collection and biochemical measurement of Approximately 10 ml of venous blood was taken from each patient after overnight fasting by sterile venipuncture, without frothing and after minimal venous stasis using disposable syringes. Blood samples were delivered in a vacutainer serum separator tubes. Immediate centrifugation at 3000 rpm was performed and then the serum was separated and divided into two portions. The first portion was used for determination of fasting blood glucose (glucose oxidase method), liver enzymes aspartate transaminase "AST", alanine transaminase "ALT" and gamma-glutamyl transaminase "GGT" (spectrophotometerially) and lipid panel (enzymatic colorimeteric method).
Improvement in HOMA IR 12 weeks following the end of treatment HOMA-IR is calculated as \[Fasting Insulin (μg/ml)\]\*\[Fasting Glucose (mmol/l)\]/22.5,HOMA-IR values between 0.5 and 1.4 are considered normal, ≥1.9 are indicative of early IR, and ≥2.9 indicate IR
Trial Locations
- Locations (1)
Tanta University
🇪🇬Tanta, Gharbia, Egypt