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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02108353
• Other study ID #: EuRhythDia II
• Status: Completed
• Phase: Phase 3
• First received: November 4, 2013
• Last updated: May 24, 2017
• Start date: January 2015
• Est. completion date: March 29, 2017

Study information

• Verified date: May 2017
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 29, 2017
• Est. primary completion date: March 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Intervention

Drug:
• Melatonin 2mg
once daily, 0.5-1 hours before going to bed and 1-2 hours after the last meal for 12 weeks.
• Placebo
once daily, 0.5-1 hours before going to bed and 1-2 hours after the last meal for 12 weeks.

Locations

Country	Name	City	State
Germany	University Medical Center Aachen	Aachen	North Rhine-Westphalia
Germany	CTC North GmbH & Co. KG	Hamburg
Italy	Department of Systems Medicine	Rome	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy (AUC)	The change in the area under the curve (AUC) of blood glucose during an oral glucose tolerance test between baseline and 12 weeks of intervention.	baseline and 12 weeks
Secondary	Efficacy BMI	The change in body weight, BMI, abdominal circumference, biomarkers and vascular function between baseline and 12 weeks of intervention and between week 12 and 24.	baseline, 12 weeks and 24 weeks
Secondary	Efficacy expression pattern of clock genes	The change in the gene expression patterns of Clock genes in peripheral blood monocytic cells (PBMC) between baseline and 12 weeks of intervention and between week 12 and 24.	baseline, 12 weeks and 24 weeks
Secondary	Efficacy glucose homeostasis (HOMA-index)	The change in the HOMA-index (Homeostasis Model Assessment) between baseline and 12 weeks of intervention and between week 12 and 24.	baseline, 12 weeks and 24 weeks
Secondary	Efficacy glucose homeostasis (QUICKI-index)	The change in the QUICKI-index (quantitative insulin sensitivity check index) between baseline and 12 weeks of intervention and between week 12 and 24.	baseline, 12 weeks and 24 weeks
Secondary	Efficacy glucose homeostasis (Stumvoll ISI-index)	The change in HbA1c between baseline and 12 weeks of intervention and between week 12 and 24.	baseline, 12 weeks and 24 weeks
Secondary	Efficacy glucose homeostasis (HbA1c)	The change in the Stumvoll ISI (Stumvoll insulin sensitivity index) between baseline and 12 weeks of intervention and between week 12 and 24.	baseline, 12 weeks and 24 weeks
Secondary	Efficacy epigenetic profiles	The differences in epigenetic profiles of genes involved in circadian rhythm between the study groups after 12 weeks of intervention and between week 12 and 24.	12 weeks and 24 weeks
Secondary	Efficacy biomarkers	The differences in plasma and serum biomarkers between baseline and 12 weeks of intervention and between week 12 and 24.	baseline, 12 weeks and 24 weeks
Secondary	Efficacy AUC Insulin 24 weeks	The change in the area under the curve (AUC) of blood insulin during an oral glucose tolerance test between week 12 and week 24 (= after 12 weeks without intervention).	12 weeks and 24 weeks
Secondary	Efficacy AUC glucose 24 weeks	The change in the area under the curve (AUC) of blood glucose during an oral glucose tolerance test between week 12 and week 24 (= after 12 weeks without intervention).	12 weeks and 24 weeks
Secondary	Efficacy AUC insulin 12 weeks	The change in the area under the curve (AUC) of blood insulin during an oral glucose tolerance test between baseline and 12 weeks of intervention.	baseline and 12 weeks

External Links

•   Trial homepage