Sleep Disorders, Circadian Rhythm Clinical Trial
Official title:
Multicenter, Randomized, Double-blind, Placebo Controlled Trial of 2 mg Melatonin for Circadian Phase Adjustment and Improvement of Metabolic Control in Night Shift Workers
EuRhythDia II is a multicenter, randomized, double-blind controlled study. The rationale of EuRhythdia is to explore the effects of 12 weeks of timed melatonin treatment on circadian rhythm, metabolic control and cardiovascular function in night shift workers. The 12 weeks of intervention will be followed by 12 weeks of washing out.
Modern lifestyle has dramatically changed the daily rhythms of life. Physical activity, diet
and light exposure are no longer restricted to daytime hours due to increased shift work.
Recent scientific reports have shown that shift work leads to disruption of circadian
rhythms and promotes diabetes, obesity and cardiovascular disease. Until now only few
studies investigating circadian rhythm disturbances in the context of type 2 diabetes and
obesity have been conducted in man. Thus, knowledge of the molecular pathways and the
responsibles genes in man are missing and have been identified only in animal studies.
The objective of the project is to achieve breakthroughs in the understanding of the
causality between inner clock rhythm disturbances and the development of type 2 diabetes and
obesity. The provided data on the interaction between genes, epigenetics, metabolism,
cardiovascular function and the internal clock are intended to contribute to identify novel
biomarkers and novel therapeutic approaches focusing on circadian rhythms to reduce the
occurence of diabetes and obesity in shift worker.
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