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EuRhythDia is a multicenter, controlled and randomized study. The aim of the study is to investigate the effects of 12 weeks of randomized timed light therapy or timed physical exercise as a chronotherapeutic lifestyle intervention on markers of central and peripheral circadian rhythms and cardiometabolic function in healthy night shift workers.
Lifestyle interventions have been recognized as important means to prevent and treat cardiometabolic disease. However, compliance of the European population to general recommendations of exercise and weight loss is unsatisfactory. There have been no studies that have attempted to convert the exciting new experimental data on the circadian clock, lifestyle, and cardiometabolic risk into diagnostic tools or novel therapeutic approaches via structured multidisciplinary efforts. One of the aims of the EuRhytDia study is to study novel applications of established lifestyle interventions by co-ordinating the timing of interventions with circadian rhythmicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | No Intervention | Control group without intervention | |
| B | Experimental | Intensive light therapy during the first half of the night shift |
|
| C | Experimental | Exercise before the beginning of the night shift |
|
| D | Experimental | Exercise after the end of the night shift |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive light therapy | Other | Light therapy will be applied by a Lumie Brazil fluorescent tube light box (10.000 lux) during the night shifts for 12 consecutive weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | The difference of the expression pattern of the CLOCK gene in peripheral blood mononuclear cells (PBMCs) after 12 weeks between intervention and control group | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | The changes in body weight, BMI, abdominal circumference from baseline to 12 weeks of intervention | 12 weeks |
| Efficacy | The differences in the circadian expression pattern of genes involved in circadian rhythm (e.g., Cryptochrome 1, Bmal 1, RORα, Rev-erbα, Period 1, Period 3, Timeless, Adam 17, PPAR-α, PPAR-γ, Klotho, DDAH-1, DDAH-2, AGXT 2, AGAT, VDR, TIMP 3) in peripheral blood mononuclear cells (PBMCs) after 12 weeks between intervention and control group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rainer Böger, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Hamburg | 20246 | Germany |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 26, 2022 | |
| Reset | Jul 21, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 26, 2022 | Jul 21, 2023 |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Exercise | Other | Physical exercise will be performed in a supervised environment on the days of the night shifts, either before the start of the shift (defined as a time period beginning no earlier than 2 hours before the start of the shift) or after the end of the night shift (defined as a time period ending no longer than 2 hours after the end of the night shift) |
|
| 12 weeks |
| Efficacy | The differences in the expression of genes involved in circadian rhythm (e.g. Cryptochrome 1, Clock, Bmal 1, RORα, Rev-erbα, Period 1, Period 3, Timeless, Adam 17, PPAR-α, PPAR-γ, Klotho, DDAH-1, DDAH-2, AGXT 2, AGAT, VDR, TIMP 3) in adipose tissue and muscle tissue, between baseline and 12 weeks of intervention (restricted to participants who consent to this part of the study | 12 weeks |
| Efficacy | The reversibility of the differences in the expression profiles of genes involved in circadian rhythm in peripheral blood mononuclear cells (PBMCs) 12 weeks after the end of the intervention period (=week 24 of the study) | 12 weeks |
| Efficacy | The differences in epigenetic profiles of genes involved in circadian rhythm between baseline and 12 weeks of intervention | 12 weeks |
| Efficacy | The reversibility of the differences in the biochemical markers and indices of cardiometabolic function (e.g. fasting glucose, fasting insulin, HOMA, OGTT, QUICKI index, Stumvoll-ISI index, HbA1c, ADMA, SDMA, fibrinogen, PAI-1, triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol, C-reactive protein, C3, systolic and diastolic blood pressure, endothelial function, IMT) 12 weeks after the end of the intervention period (=week 24 of the study) | 12 weeks |
| Efficacy | The differences in metabolomic profiling between baseline, 12 weeks of intervention, and after 12 weeks of wash-out (Plasma samples will be collected for metabolomic analysis at these time points) | 12 weeks |