Abstract

Objective: This study evaluated the effect of melatonin on the response of patients suffering from metabolic syndrome (MEBS) treated with metformin. Design: This study used two-armed groups in a double-blind, randomized controlled clinical trial. Materials and Methods: A randomized double-blind placebo-controlled study was carried out on female patients diagnosed as having MEBS, according to the International Diabetes Federation (IDF) diagnosing criteria of MEBS (2005), from the outpatient clinic in Al-Zahraa Teaching Hospital/Kut, Iraq. They were diagnosed utilizing laboratory and clinical investigations, then randomized into two groups. The first group (group A) was treated with metformin (500 mg) twice daily, in addition to a placebo formula once daily at bedtime for three months. The second group (group B) was treated with metformin (500 mg) twice daily after meals, in addition to melatonin (10 mg) once daily at bedtime for three months. Results: The treatment of patients with MEBS using metformin–melatonin showed an improvement in most MEBS components such as fasting serum glucose (FSG), lipid profile, and body mass index (BMI), in addition to a reduction in insulin resistance and hyperinsulinemia. Simultaneously, there were increments in serum uric acid (UA), leptin, prolactin (PRL), and estradiol levels, while serum progesterone level decreased. Furthermore, patients treated with metformin–placebo showed less improvement in the studied parameters compared to that produced due to the inclusion of melatonin in the treatment protocol. Conclusion: Melatonin improves the effect of metformin on several components of MEBS such as FSG, lipid profile, and BMI, in addition to insulin resistance and hyperinsulinemia, compared to metformin alone.

Highlights

  • Metabolic syndrome (MEBS) refers to the clustering of several cardiometabolic risk factors, including abdominal obesity, hyperglycemia, dyslipidemia, and elevated blood pressure (BP), which are linked to insulin resistance [1]

  • Insulin resistance is the essential cause of MEBS [4], and it usually presents with MEBS, while it is strongly associated with other metabolic risk factors and correlates univariately with cardiovascular disease (CVD) risk [5]

  • We suggest that insulin receptor substrate 1 (IRS-1) phosphorylation may play a role as a converging target in insulin- and melatonin-stimulated signaling pathways, as well as a probable link for both hormones in the control of body weight and carbohydrate metabolism

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Summary

Introduction

Metabolic syndrome (MEBS) refers to the clustering of several cardiometabolic risk factors, including abdominal obesity, hyperglycemia, dyslipidemia, and elevated blood pressure (BP), which are linked to insulin resistance [1]. MEBS is highly prevalent and is a risk factor for cardiovascular disease (CVD), chronic kidney disease (CKD), and type II diabetes [2]. This constellation of risk factors increases the risk of diabetes by 5–9-fold and cardiovascular mortality by 2–3-fold [3]. Insulin resistance is the essential cause of MEBS [4], and it usually presents with MEBS, while it is strongly associated with other metabolic risk factors and correlates univariately with CVD risk [5].

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