Effect of Melatonin and Metformin on Glycemic Control Genotoxicity and Cytotoxicity Markers in Patients With Prediabetes

Effect of the Administration of Melatonin and Metformin on Glycemic Control, Genotoxicity and Cytotoxicity Markers in Patients With Prediabetes: Pilot Study

Melatonin is a hormone that regulates the circadian cycle in addition to having an antioxidant effect. Patients with prediabetes state, has a deregulation of glucose metabolism and an overproduction of reactive oxygen species caused by levels of hyperglycemia that generate DNA modification in pancreatic beta cells, which leads to apoptosis and a deficient production of insulin. The administration of metformin and melatonin could be a possibility to treat and reverse the prediabetic state decreasing the glycemic levels and reactive oxygen species production.

A randomized, double blind, placebo-controlled, pilot clinical trial will carried out in 42 patients with a diagnosis of prediabetes, according to the American Diabetes Association criteria. The patients will be divide in three groups administrating metformin plus placebo, melatonin plus placebo or melatonin plus metformin. The intervention will be with 500 mg lengthed release tablets of metformin once a day in the morning, per 90 days, 5 mg lengthed release capsules of melatonin one a day in the night per 90 days and calcined magnesia as a placebo. Before and after the intervention, will be evaluate: fasting plasma glucose, blood glucose after an oral glucose tolerance test, A1c hemoglobin fraction, micronuclei frequency, nuclear anomalies frequency, insulin secretion and insulin sensitivity, weight, height, body mass index, triglycerides, total cholesterol, high-density lipoprotein, low-density lipoprotein, creatinine, uric acid, and sleep quality.

Inclusion Criteria:

• Age beween 30 to 60 years old.
• Diagnosis of Prediabetes state according to the American Diabetes Association criteria.
• Without pharmacological treatment.
• Body mass index between 25 to 34.9 Kg/m2
• Sign informed consent

Exclusion Criteria:

• Patients with pharmacological treatment.
• Pregnant woman
• Patients with autoimmune, cancer, reumatic diases history or with pharmaceutical treatment
• Workers on night or changing shifts.
• Subjects that have been exposed to radiation
• Dyslipidemia: Total cholesterol >250mg/dL, Triglycerides >500 mg/dL.
• Subjects that have travel to other place with a different time zone.
• Patients with diagnosis of insomnia
• Patients with a glomerular filtration <60 ml/min using the Cockroft-Gault Formula.