Sleep Disorders, Circadian RhythmPhase 3NCT02108353
Circadian Phase Adjustment and Improvement of Metabolic Control in Night Shift Workers
A Phase 3 study testing Melatonin 2mg in people with Sleep Disorders, Circadian Rhythm, run by Universitätsklinikum Hamburg-Eppendorf at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorders, Circadian Rhythm
- What is being tested?
- Melatonin 2mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2015to 29 Mar 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
University Medical Center Aachen
Aachen, North Rhine-Westphalia, 52074
CTC North GmbH & Co. KG
Hamburg, 20246
About this study
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
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.
Read the 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.
- Conditions
- Sleep Disorders, Circadian Rhythm
- Being tested
- Melatonin 2mg, Placebo
- Keywords
- Type 2 Diabetes, metabolic control, Metabolomics, Circadian Rhythm, Melatonin, Biomarker, Clock Gene, PBMC, Cardiovascular function, Epigenetic modification, Lifestyle Intervention
- Medical subject headings
- Sleep Disorders, Circadian Rhythm, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 2mgDrug
Also called Circadin®
once daily, 0.5-1 hours before going to bed and 1-2 hours after the last meal for 12 weeks.
PlaceboDrug
Also called None active substances
once daily, 0.5-1 hours before going to bed and 1-2 hours after the last meal for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin 2mg | Active comparator | The study medication will be compared to placebo control. Receives: Drug: Melatonin 2mg |
| Placebo | Placebo comparator | The study medication will be compared to placebo control. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 12 weeks
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 12 weeks and 24 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startJan 2015
- Primary completion29 Mar 2017
- Study completion29 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorders, Circadian RhythmStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rainer H Boeger, MD, Study chair, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108353
- Sponsor's protocol ID
- EuRhythDia II
- Status last verified
- May 2017
- First submitted
- 4 Nov 2013
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02108353
- Acronym / sponsor ID
- EuRhythDia II
- Conditions
- Sleep Disorders, Circadian Rhythm
- Keywords
- Type 2 Diabetes, metabolic control, Metabolomics, Circadian Rhythm, Melatonin, Biomarker, Clock Gene, PBMC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 29 Mar 2017 (actual)
- Study completion
- 29 Mar 2017 (actual)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin 2mg | Active comparator | Drug: Melatonin 2mgThe study medication will be compared to placebo control. |
| Placebo | Placebo comparator | Drug: PlaceboThe study medication will be compared to placebo control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 2mgAlso: Circadin®once daily, 0.5-1 hours before going to bed and 1-2 hours after the last meal for 12 weeks. | Drug | Melatonin 2mg |
| PlaceboAlso: None active substancesonce daily, 0.5-1 hours before going to bed and 1-2 hours after the last meal for 12 weeks. | Drug | Placebo |
Primary outcome
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.
11 secondary outcomes
Efficacy BMI
Time frame: baseline, 12 weeks and 24 weeks
Efficacy expression pattern of clock genes
Time frame: baseline, 12 weeks and 24 weeks
Efficacy glucose homeostasis (HOMA-index)
Time frame: baseline, 12 weeks and 24 weeks
Efficacy glucose homeostasis (QUICKI-index)
Time frame: baseline, 12 weeks and 24 weeks
Efficacy glucose homeostasis (Stumvoll ISI-index)
Time frame: baseline, 12 weeks and 24 weeks
Efficacy glucose homeostasis (HbA1c)
Time frame: baseline, 12 weeks and 24 weeks
Efficacy epigenetic profiles
Time frame: 12 weeks and 24 weeks
Efficacy biomarkers
Time frame: baseline, 12 weeks and 24 weeks
Efficacy AUC Insulin 24 weeks
Time frame: 12 weeks and 24 weeks
Efficacy AUC glucose 24 weeks
Time frame: 12 weeks and 24 weeks
Efficacy AUC insulin 12 weeks
Time frame: baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Trial homepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer H Boeger, MD study chair
Universitätsklinikum Hamburg-Eppendorf
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Melatonin 2mg in people with Sleep Disorders, Circadian Rhythm, run by Universitätsklinikum Hamburg-Eppendorf at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (AUC) (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2017.