NCT02108353

Circadian Phase Adjustment and Improvement of Metabolic Control in Night Shift Workers

Multicenter, Randomized, Double-blind, Placebo Controlled Trial of 2 mg Melatonin for Circadian Phase Adjustment and Improvement of Metabolic Control in Night Shift Workers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Sleep Disorders, Circadian Rhythm

Interventions

Type	Name	Description
DRUG	Melatonin 2mg	once daily, 0.5-1 hours before going to bed and 1-2 hours after the last meal for 12 weeks.
DRUG	Placebo	once daily, 0.5-1 hours before going to bed and 1-2 hours after the last meal for 12 weeks.

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-03-29
• Completion: 2017-03-29
• First posted: 2014-04-09
• Last updated: 2017-05-25

Locations

3 sites across 2 countries: Germany, Italy