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Completed

NCT Number: NCT02108353

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.

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Key information

Conditions

Sleep Disorders, Circadian Rhythm Chronobiology Disorders Diabetes Mellitus Diabetes Mellitus, Type 2 Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Occupational Diseases Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Medical Center Aachen, Aachen, North Rhine-Westphalia, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin 2mg

Drug

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

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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).

  11. 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.

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 9, 2014
Registry last updated
May 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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