1. Introduction
amaurosis, ’s blood glucose, disorders of quality, duration and sleep, sleep disturbances, renal failure, chronic microvascular complications, apnea, hyperglycemia, hypoglycemia, lower limb amputations, type 2 diabetes mellitus, T2DM
TYPE 2 DIABETES MELLITUS, DISEASE, RENAL FAILURE, HYPERGLYCEMIA, HYPOGLYCEMIA, AMAUROSIS, TYPE 2 DIABETES MELLITUS, COMPLICATIONS
Background: Glycemic variability in patients with type 2 diabetes mellitus (T2DM) may be associated with chronic complications of the disease. Melatonin is a hormone that plays a crucial role in biological rhythms. Previous studies have indicated that individuals with T2DM often exhibit reduced melatonin production. In this study, our objective was to investigate whether nighttime melatonin supplementation could mitigate glycemic variability in these patients. Methods: Crossover, double-blind, placebo-controlled, randomized study. A total of 30 patients were enrolled in this study. The study included 15 participants who followed the intervention sequence of placebo (7 days)—washout (7 days)—melatonin (3 mg) (7 days), and another 15 participants who followed the sequence of melatonin (3 mg) (7 days)—washout (7 days)—placebo (7 days). During the final three days of the first and third weeks, the participants measured their pre- and postprandial capillary blood glucose levels. This study was reported according to the CONSORT 2010 statement: extension to randomized crossover trials. Results: There was a significant absolute difference in the breakfast blood glucose levels (Type 2 diabetes mellitus (T2DM) is a disease characterized by hyperglycemia, which, if not properly treated, can lead to acute and chronic complications such as amaurosis, lower limb amputations and renal failure [The glycemic control of patients with T2DM is assessed using the glycohemoglobin molecule (HbA1c), which reflects the average blood glucose levels over the past three months. Patients with unstable glycemic control, experiencing both hyperglycemia and hypoglycemia episodes, may have misleading HbA1c results that appear to be within the target range [Recent studies have supported the hypothesis that a certain range of glycemic variation throughout the day, even with the nadir and peak of glycemia at the target, may contribute to chronic microvascular complications in T2DM, as occurs with chronic hyperglycemia [Previous studies have attributed an increased risk of developing type 2 diabetes mellitus to sleep disturbances (disorders of quality, duration and sleep apnea) [Melatonin is a complex molecule, whose feedback is not as simple as that of other hormones. It is necessary to understand well the physiology of endogenous melatonin as well as the pharmacology of exogenous melatonin in order to establish its relationship with the diurnal rhythm of glucose levels throughout the day. Another important point is to define the concept of glycemic variability. There are several ways to assess whether a patient has abnormal variation in their blood glucose or not. These differences may simply be conceptual, based on various mathematical calculations, or technological, as there are different ways of measuring a patient’s blood glucose, some using cutting-edge technologies with high costs [To evaluate the role of exogenous melatonin in the glycemic variability in patients with T2DM, we developed a crossover, double-blind, placebo-controlled and randomized study. Before detailing the design of the work, some concepts will be detailed, such as glycemic variability and characteristics of endogenous and exogenous melatonin.