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

January 3, 2017 updated by: Tom Forsén, University of Helsinki

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Jakobstad, Finland, 68660
        • Botniacentret Jakobstad
      • Vasa, Finland, 65200
        • Vasa health care centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetes
  • Positive GAD-ab
  • Sever dysregulated hypertension
  • glaucoma
  • severe coronary heart disease or arrythmias
  • previous or ongoing severe ventricle or duodenal ulcer
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melatonin
melatonin 4mg od for 3 months
Drug: Melatonin
All subjects receive the same dose of melatonin
Other Names:
  • Circadin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose tolerance
Time Frame: 3 months
Glucose tolerance is measured in OGTT: 0,30,60,90 and 120 minute values of glucose and insulin.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleep
Time Frame: 3 months
monitoring of sleep with questionnaires and activity monitoring
3 months
Activity
Time Frame: 3 months
Activity and sleep of the subjects is recorded with Actigraph at 0 and 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

Lund University
Folkhälsan Research Center

Investigators

  • Study Chair: Leif Groop, Prof., University of Lund, University of Helsinki
  • Study Director: Tiinamaija Tuomi, Docent, Helsinki University Central Hospital
  • Principal Investigator: Bo Isomaa, Docent, Folkhalsan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

October 10, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (Estimate)

October 12, 2012

Study Record Updates

Last Update Posted (Estimate)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT-2011-005360-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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