NCT02108353

Brief 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. The 12 weeks of intervention will be followed by 12 weeks of washing out.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2015

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2017

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

2.2 years

First QC Date

November 4, 2013

Last Update Submit

May 24, 2017

Conditions

Sleep Disorders, Circadian Rhythm

Keywords

Type 2 Diabetesmetabolic controlMetabolomicsCircadian RhythmMelatoninBiomarkerClock GenePBMCCardiovascular functionEpigenetic modificationLifestyle Intervention

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline and 12 weeks

Secondary Outcomes (11)

  • Efficacy BMI

    baseline, 12 weeks and 24 weeks

  • Efficacy expression pattern of clock genes

    baseline, 12 weeks and 24 weeks

  • Efficacy glucose homeostasis (HOMA-index)

    baseline, 12 weeks and 24 weeks

  • Efficacy glucose homeostasis (QUICKI-index)

    baseline, 12 weeks and 24 weeks

  • Efficacy glucose homeostasis (Stumvoll ISI-index)

    baseline, 12 weeks and 24 weeks

  • +6 more secondary outcomes

Study Arms (2)

Melatonin 2mg

ACTIVE COMPARATOR

The study medication will be compared to placebo control.

Drug: Melatonin 2mg

Placebo

PLACEBO COMPARATOR

The study medication will be compared to placebo control.

Drug: Placebo

Interventions

Melatonin 2mgDRUG

once daily, 0.5-1 hours before going to bed and 1-2 hours after the last meal for 12 weeks.

Also known as: Circadin®
Melatonin 2mg
PlaceboDRUG

once daily, 0.5-1 hours before going to bed and 1-2 hours after the last meal for 12 weeks.

Also known as: None active substances
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female above the age of 18

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Medical Center Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

CTC North GmbH & Co. KG

Hamburg, 20246, Germany

Location

Department of Systems Medicine

Rome, Lazio, 00133, Italy

Location

Related Links

MeSH Terms

Conditions

Sleep Disorders, Circadian RhythmDiabetes Mellitus, Type 2

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Chronobiology DisordersNervous System DiseasesDyssomniasSleep Wake DisordersOccupational DiseasesMental DisordersDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Rainer H Boeger, MD

    Universitätsklinikum Hamburg-Eppendorf

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2013

First Posted

April 9, 2014

Study Start

January 1, 2015

Primary Completion

March 29, 2017

Study Completion

March 29, 2017

Last Updated

May 25, 2017

Record last verified: 2017-05

Locations

IT(1)DE(2)