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

May 24, 2017 updated by: Universitätsklinikum Hamburg-Eppendorf

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • CTC North GmbH & Co. KG
    • North Rhine-Westphalia
      • Aachen, North Rhine-Westphalia, Germany, 52074
        • University Medical Center Aachen
  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00133
        • Department of Systems Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Melatonin 2mg
The study medication will be compared to placebo control.
Drug: Melatonin 2mg
once daily, 0.5-1 hours before going to bed and 1-2 hours after the last meal for 12 weeks.
Other Names:
  • Circadin®
Placebo Comparator: Placebo
The study medication will be compared to placebo control.
Drug: Placebo
once daily, 0.5-1 hours before going to bed and 1-2 hours after the last meal for 12 weeks.
Other Names:
  • None active substances

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy (AUC)
Time Frame: baseline and 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy BMI
Time Frame: baseline, 12 weeks and 24 weeks
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
Efficacy expression pattern of clock genes
Time Frame: baseline, 12 weeks and 24 weeks
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
Efficacy glucose homeostasis (HOMA-index)
Time Frame: baseline, 12 weeks and 24 weeks
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
Efficacy glucose homeostasis (QUICKI-index)
Time Frame: baseline, 12 weeks and 24 weeks
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
Efficacy glucose homeostasis (Stumvoll ISI-index)
Time Frame: baseline, 12 weeks and 24 weeks
The change in HbA1c between baseline and 12 weeks of intervention and between week 12 and 24.
baseline, 12 weeks and 24 weeks
Efficacy glucose homeostasis (HbA1c)
Time Frame: baseline, 12 weeks and 24 weeks
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
Efficacy epigenetic profiles
Time Frame: 12 weeks and 24 weeks
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
Efficacy biomarkers
Time Frame: baseline, 12 weeks and 24 weeks
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
Efficacy AUC Insulin 24 weeks
Time Frame: 12 weeks and 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
Efficacy AUC glucose 24 weeks
Time Frame: 12 weeks and 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
Efficacy AUC insulin 12 weeks
Time Frame: baseline and 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Study Chair: Rainer H Boeger, MD, Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

March 29, 2017

Study Completion (Actual)

March 29, 2017

Study Registration Dates

First Submitted

November 4, 2013

First Submitted That Met QC Criteria

April 5, 2014

First Posted (Estimate)

April 9, 2014

Study Record Updates

Last Update Posted (Actual)

May 25, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EuRhythDia II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep Disorders, Circadian Rhythm

Clinical Trials on Melatonin 2mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe