Overview

This trial is active, not recruiting.

Condition sleep disorders, circadian rhythm
Treatments melatonin 2mg, placebo
Phase phase 3
Sponsor Universitätsklinikum Hamburg-Eppendorf
Start date January 2015
End date August 2016
Trial size 144 participants
Trial identifier NCT02108353, EuRhythDia II

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Active Comparator)
The study medication will be compared to placebo control.
melatonin 2mg Circadin®
once daily, 0.5-1 hours before going to bed and 1-2 hours after the last meal for 12 weeks.
(Placebo Comparator)
The study medication will be compared to placebo control.
placebo None active substances
once daily, 0.5-1 hours before going to bed and 1-2 hours after the last meal for 12 weeks.

Primary Outcomes

Measure
Efficacy (AUC)
time frame: baseline and 12 weeks

Secondary Outcomes

Measure
Efficacy BMI
time frame: baseline, 12 weeks and 24 weeks
Efficacy expression pattern of clock genes
time frame: baseline, 12 weeks and 24 weeks
Efficacy glucose homeostasis (HOMA-index)
time frame: baseline, 12 weeks and 24 weeks
Efficacy glucose homeostasis (QUICKI-index)
time frame: baseline, 12 weeks and 24 weeks
Efficacy glucose homeostasis (Stumvoll ISI-index)
time frame: baseline, 12 weeks and 24 weeks
Efficacy glucose homeostasis (HbA1c)
time frame: baseline, 12 weeks and 24 weeks
Efficacy epigenetic profiles
time frame: 12 weeks and 24 weeks
Efficacy biomarkers
time frame: baseline, 12 weeks and 24 weeks
Efficacy AUC Insulin 24 weeks
time frame: 12 weeks and 24 weeks
Efficacy AUC glucose 24 weeks
time frame: 12 weeks and 24 weeks
Efficacy AUC insulin 12 weeks
time frame: baseline and 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Male and female above the age of 18 - Night shift workers on regular night shifts (at least 6 months before inclusion into the study and at least 4 night shifts per month during the study period Exclusion Criteria: - pregnancy or breast feeding - Known autoimmune disease - Current or relevant history of physical or psychiatric illness - Evidence of renal insufficiency or liver disease - Known or suspected intolerance or hypersensitivity to the study medication - Use of certain drugs within 4 weeks prior to the inclusion to the study

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Universitätsklinikum Hamburg-Eppendorf.