drugset / Trial / NCT03848533

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

NCT03848533

Phase 2 Unknown 42 enrolled University of Guadalajara
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2019-08-22
Primary completion
2021-08
Completion
2021-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Melatonin Small molecule 5 mg
Subject Metformin Small molecule 500 mg
Subject Metformin Small molecule 850 mg

Indications