A Randomized Open Label Active Control Phase IV Clinical Study Evaluating Efficacy and Safety of Resveratrol As an Adjuvant Therapy in Patients with Diabetes Dyslipidemia and Hypertension

Abstract

OBJECTIVES: The aim of this study was to investigate the efficacy and safety of resveratrol as an adjuvant therapy in newly diagnosed type 2 diabetes mellitus (T2DM) patients with borderline dyslipidemia (Diabetes study), in newly diagnosed dyslipidaemia patients (dyslipidemia study) and newly diagnosed hypertensive patients (hypertension study). newlineSUBJECTS AND METHODS: In this randomized active-controlled study, T2DM patients (male/female) aged 20-65 years with borderline dyslipidemia (hypolipidemic naïve patients) were randomized to receive glimepiride 2mg or glimepiride 2mg plus resveratrol 1 gram daily for 12 months (for Diabetes study). In dyslipidemia study, dyslipidaemia patients (male/female) aged 20-65 years were randomized to receive (1:1) either atorvastatin (10 mg daily) or atorvastatin (10 mg daily) plus resveratrol (500mg twice daily) as adjuvant therapy for 12 months. In hypertension study, patients with Stage I hypertension (SBP 140 159 mmHg and DBP 90 99 mmHg)) were randomized to receive telmisartan 20 mg or telmisartan 20 mg plus resveratrol 1 gram daily for 12 months. In Diabetes study, change in plasma blood glucose (fasting and postprandial); glycosylated hemoglobin (HbA1c); and lipid profile (total cholesterol [TC], Triglycerides [TG], low-density lipoprotein [LDL] and high-density lipoprotein [HDL]) from baseline was assessed. In dyslipidemia study, change in lipid profile (total cholesterol [TC], Triglycerides [TG], low-density lipoprotein [LDL] and high-density lipoprotein [HDL]) from baseline was assessed. In hypertension study, change in systolic blood pressure and diastolic blood pressure from baseline was assessed. Efficacy variable was measured at every 3 months for 12 months for Diabetes, dyslipidaemia and hypertension study. Treatment-emergent adverse events (TEAEs) were assessed at every 3 months for 12 months for Diabetes, dyslipidaemia and hypertension study. newline newline