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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Guadalajara
• Treatments: Melatonin; Metformin

Criteria

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.