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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
46
once daily, 0.5-1 hours before going to bed and 1-2 hours after the last meal for 12 weeks.
once daily, 0.5-1 hours before going to bed and 1-2 hours after the last meal for 12 weeks.
University Medical Center Aachen
Aachen, North Rhine-Westphalia, Germany
CTC North GmbH & Co. KG
Hamburg, Germany
Department of Systems Medicine
Rome, Lazio, Italy
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.
Time frame: baseline and 12 weeks
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.
Time frame: baseline, 12 weeks and 24 weeks
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.
Time frame: baseline, 12 weeks and 24 weeks
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.
Time frame: baseline, 12 weeks and 24 weeks
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.
Time frame: baseline, 12 weeks and 24 weeks
Efficacy glucose homeostasis (Stumvoll ISI-index)
The change in HbA1c between baseline and 12 weeks of intervention and between week 12 and 24.
Time frame: baseline, 12 weeks and 24 weeks
Efficacy glucose homeostasis (HbA1c)
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The change in the Stumvoll ISI (Stumvoll insulin sensitivity index) between baseline and 12 weeks of intervention and between week 12 and 24.
Time frame: baseline, 12 weeks and 24 weeks
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.
Time frame: 12 weeks and 24 weeks
Efficacy biomarkers
The differences in plasma and serum biomarkers between baseline and 12 weeks of intervention and between week 12 and 24.
Time frame: baseline, 12 weeks and 24 weeks
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).
Time frame: 12 weeks and 24 weeks
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).
Time frame: 12 weeks and 24 weeks
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.
Time frame: baseline and 12 weeks