Dyslipidemia and Type 2 Diabetes Mellitus. E78: Disorders of lipoprotein metabolism and other lipidemias (for dyslipidemia)E11: Type 2 diabetes mellitus
Conditions
Interventions
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 man
Sponsors
Islamic Azad University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: · 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.
Exclusion criteria
Exclusion criteria: · 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNasrin Razavianzadeh
Islamic Azad University
Outcome results
None listed