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DiabetesPhase 3MELAGNCT01705639

Melatonin and Glucose Tolerance Among Individuals With a Variant of the MTNR1B Gene

A Phase 3 study testing Melatonin in people with Diabetes and Glucose Tolerance, run by University of Helsinki at 2 sites in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The effect of 3 months of melatonin 4mg treatment on glucose tolerance in different variants of the melatonin receptor 1B gene will be evaluated. The following will be done at 0 and 3 months: OGTT questionnaires about sleep and activity Actigraph Anthropometry Blood pressure Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes, Glucose Tolerance
What is being tested?
Melatonin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
2 sitesFinland
Study dates
Nov 2012to Aug 2014
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 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • signed informed concent
  • Known genotype for MTNR1B from the Botnia-ppp study
  • Age 18-75 years

Who cannot join

  • Diabetes
  • Positive GAD-ab
  • Sever dysregulated hypertension
  • glaucoma
  • severe coronary heart disease or arrythmias
  • previous or ongoing severe ventricle or duodenal ulcer
Show all 16Show fewer
  • psychosis or anxiety disorder
  • regular use of sleep pills, antidepressants or neuroleptics
  • creatinine > 130 µmol/L
  • elevated liver enzymes (ASAT, ALAT, ALP, GT, bilirubin) > 3 times reference value
  • inability to sign informed concent
  • other factor with according to the physician may affect treatment or results.
  • participation in other clinical study
  • allergy to melatonin or other substance in the capsule
  • hereditary galactose intolerance or glucose/galactose malabsorption
  • intention to become pregnant

Trial locations and contacts

2 sites in 1 country.

Finland2 sites

  • Botniacentret Jakobstad

    Jakobstad, 68660

  • Vasa health care centre

    Vaasa, 65200

Other trials in Finland

About this study

Official title: Does Melatonin Treatment Affect Glucose Tolerance Among Individuals With a Variant (rs10830963) of the Melatonin Receptor 1B (MTNR1B) Gene?

The effect of 3 months of melatonin 4mg treatment on glucose tolerance in different variants of the melatonin receptor 1B gene will be evaluated. The following will be done at 0 and 3 months:

  • OGTT
  • questionnaires about sleep and activity
  • Actigraph
  • Anthropometry
  • Blood pressure
Read the detailed description

http://www.sciencedirect.com/science/article/pii/S1550413116301607

Being tested
Melatonin
Keywords
diabetes, melatonin, glucose tolerance, sleep
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MelatoninDrug

    Also called Circadin

    All subjects receive the same dose of melatonin

Study groups in NCT01705639
Study groupRoleWhat they receive
MelatoninExperimentalmelatonin 4mg od for 3 months
Receives: Drug: Melatonin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glucose tolerance

    Glucose tolerance is measured in OGTT: 0,30,60,90 and 120 minute values of glucose and insulin.

    Measured: 3 months

Secondary outcomes (2)

  1. sleep

    monitoring of sleep with questionnaires and activity monitoring

    Measured: 3 months

  2. Activity

    Activity and sleep of the subjects is recorded with Actigraph at 0 and 3 months

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionAug 2014
  4. Study completionAug 2014

Resources

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01705639
Sponsor's protocol ID
EudraCT-2011-005360-22
Acronym
MELAG
Status last verified
Jan 2017
First submitted
10 Oct 2012
Last updated
4 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Tuomi T, Nagorny CLF, Singh P, Bennet H, Yu Q, Alenkvist I, Isomaa B, Ostman B, Soderstrom J, Pesonen AK, Martikainen S, Raikkonen K, Forsen T, Hakaste L, Almgren P, Storm P, Asplund O, Shcherbina L, Fex M, Fadista J, Tengholm A, Wierup N, Groop L, Mulder H. Increased Melatonin Signaling Is a Risk Factor for Type 2 Diabetes. Cell Metab. 2016 Jun 14;23(6):1067-1077. doi: 10.1016/j.cmet.2016.04.009. Epub 2016 May 12.

    PubMed 27185156

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Melatonin in people with Diabetes and Glucose Tolerance, run by University of Helsinki at 2 sites in Finland.

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 3 inclusion and 16 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 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Finland. 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. 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?

Glucose tolerance (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01705639, which also lists 1 linked publication.

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 4 Jan 2017.

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