drugset / Trial / NCT03859934

Metabolic Effects of Melatonin Treatment

NCT03859934

RandomizedCrossoverTriple-blindTreatment

Summary

Modern living is associated with an epidemic of type 2 diabetes mellitus (T2DM). Sleep disturbances such as insomnia or frequent awakenings are strong risk factors for T2DM with several studies indicating a central role of melatonin. Additionally, a certain single nucleotide polymorphism in the melatonin receptor gene, MTNR1B rs10830963, with an allele frequency of 30 %, is associated with increased fasting plasma glucose and T2DM. Due to treatment of, among other things, insomnia, the use of melatonin is increasing rapidly in Denmark with a 100-fold increase from 2007-2012 in children and adolescents. No previous studies have thoroughly assessed changes in glucose and fatty acid metabolism after 3 months of melatonin treatment in patients with T2DM.

Timeline

Start
2019-09-26
Primary completion
2021-05-03
Completion
2021-08-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator Melatonin Small molecule 10 mg Oral