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IRCT20250718066536N1 IRCT 2025-07-25 Islamic Azad University Comparison of daily and every-other-day combination therapy with statins and fibrates in patients with combined hyperlipidemia Daily versus Alternate-Day Combination Therapy with Atorvastatin and Fenofibrate in mixed hyperlipidemia 2025-08-19 anticipated 90 Recruiting https://irct.ir/trial/84894 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Write the name, code or number of each member on a piece of paper and then place it in a box or container and mix them well. Then take the paper according to the sample size and select the samples. Finally, from the list and according to the code given to each member or the number of each member, the samples are identified. 2 Dyslipidemia and Type 2 Diabetes Mellitus. Intervention Group 1: Daily Treatment GroupPatients received atorvastatin (10 or 20 mg, oral, once daily) and fenofibrate (100 mg, oral, once daily) for 12 weeks. Atorvastatin and fenofibrate were manufactured by [Insert Manufacturer Name], and the dosage was determined based on clinical guidelines and patient-specific factors.Intervention Group 2: Alternate-Day Treatment GroupPatients received atorvastatin (10 or 20 mg, oral, every other day) and fenofibrate (100 mg, oral, every other day) for 12 weeks. Atorvastatin and fenofibrate were manufactured by [Insert Manufacturer Name], with the alternate-day dosing schedule designed to assess efficacy and tolerability compared to daily dosing.. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no plan to share individual participant data (IPD) due to concerns regarding participant privacy and confidentiality, as well as restrictions imposed by the institutional ethics committee at Khatam Hospital. The study team prioritizes protecting sensitive participant information, and only aggregated data will be published to ensure compliance with ethical and regulatory requirements.

public Nasrin Razavianzadeh

Hesabi avenue

Shahrood Iran (Islamic Republic of) 7157759318 +98 71 3740 8566 soheil.rad2019@gmail.com Islamic Azad University scientific Nasrin Razavianzadeh

Hesabi avenue

Shahrood Iran (Islamic Republic of) 7157759318 +98 71 3740 8566 soheil.rad2019@gmail.com Islamic Azad University Iran (Islamic Republic of) · LDL-C exceeds 100 mg/dL and triglycerides surpass 200 mg/dL, indicating mixed dyslipidemia. The Body Mass Index (BMI) ranges from 18.5 to 40 kg/m². · Diabetes treatment that has been maintained for a minimum of three months prior to enrollment. Ability to provide written informed consent. 18 years 80 years Both · Ongoing treatment for dyslipidemia four weeks prior to enrollment.· Triglyceride concentrations exceeding 500 mg/dL (5.6 mmol/L).· Active hepatic disease occurs when liver enzymes (SGOT, SGPT, or alkaline phosphatase) exceed three times the normal upper limit.· Renal impairment characterized by a serum creatinine concentration exceeding 1.6 mg/dL (141 μmol/L) or an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m².· Unmanaged Type 2 Diabetes Mellitus (HbA1c >7% and fasting blood glucose >126 mg/dL [7.0 mmol/L]).· Hypothyroidism occurs when thyroid-stimulating hormone levels exceed 5 IU/mL.· A history of myopathy or creatine phosphokinase (CPK) levels exceeding five times the normal upper limit.· A recent heart attack, coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, or stroke occurring within the last six months.· Additional medications that may influence the metabolism of the study drug in the body (e.g., cytochrome P450 3A4 inhibitors).· Women undergoing hormone replacement therapy post-menopause.· Pregnant or breastfeeding women.· Patients unwilling to provide informed consent. E78 (Dysli E78: Disorders of lipoprotein metabolism and other lipidemias (for dyslipidemia)E11: Type 2 diabetes mellitus Treatment - Drugs Intervention Group 1: Daily Treatment GroupPatients received atorvastatin (10 or 20 mg, oral, once daily) and fenofibrate (100 mg, oral, once daily) for 12 weeks. Atorvastatin and fenofibrate were manufactured by [Insert Manufacturer Name], and the dosage was determined based on clinical guidelines and patient-specific factors.Intervention Group 2: Alternate-Day Treatment GroupPatients received atorvastatin (10 or 20 mg, oral, every other day) and fenofibrate (100 mg, oral, every other day) for 12 weeks. Atorvastatin and fenofibrate were manufactured by [Insert Manufacturer Name], with the alternate-day dosing schedule designed to assess efficacy and tolerability compared to daily dosing. Primary Outcome Variable 1: Reduction in low-density lipoprotein cholesterol (LDL-C) levels (mg/dL)Description: The primary outcome is the change in LDL-C levels, measured as the difference between baseline and 12-week post-treatment values in patients with dyslipidemia and type 2 diabetes mellitus.Primary Outcome Variable 2: Reduction in triglyceride (TG) levels (mg/dL)Description: The primary outcome is the change in TG levels, measured as the difference between baseline and 12-week post-treatment values in patients with dyslipidemia and type 2 diabetes mellitus. Timepoint: Time Points: Measurements of low-density lipoprotein cholesterol (LDL-C) and triglyceride (TG) levels were taken at baseline (before intervention) and after 12 weeks of treatment. Method of measurement: Method for LDL-C: Measured using the Pars Azmoon Lipid Profile Kit with standardized enzymatic methods.Method for TG: Measured using the Pars Azmoon Lipid Profile Kit with standardized enzymatic methods. No Approved 2024-03-16 Ethics Committee of Islamic Azad University, Shahrood Branch Heasabi avenue Shahrood Semnan Iran (Islamic Republic of)