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

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ClinicalTrials.gov Identifier: NCT01705639
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : January 4, 2017
Sponsor:
Collaborators:
Lund University
Folkhalsan Research Center
Information provided by (Responsible Party):
Tom Forsén, University of Helsinki

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Diabetes Glucose Tolerance Drug: Melatonin Phase 3

Detailed Description:
http://www.sciencedirect.com/science/article/pii/S1550413116301607
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Does Melatonin Treatment Affect Glucose Tolerance Among Individuals With a Variant (rs10830963) of the Melatonin Receptor 1B (MTNR1B) Gene?
Study Start Date : November 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Melatonin
melatonin 4mg od for 3 months
 Drug: Melatonin
All subjects receive the same dose of melatonin
Other Name: Circadin


Outcome Measures
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Primary Outcome Measures :
  1. Glucose tolerance [ Time Frame: 3 months ]
    Glucose tolerance is measured in OGTT: 0,30,60,90 and 120 minute values of glucose and insulin.


Secondary Outcome Measures :
  1. sleep [ Time Frame: 3 months ]
    monitoring of sleep with questionnaires and activity monitoring

  2. Activity [ Time Frame: 3 months ]
    Activity and sleep of the subjects is recorded with Actigraph at 0 and 3 months


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705639


Locations
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Finland
Botniacentret Jakobstad
Jakobstad, Finland, 68660
Vasa health care centre
Vasa, Finland, 65200
Sponsors and Collaborators
University of Helsinki
Lund University
Folkhalsan Research Center
Investigators
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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
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Tom Forsén, MD PhD, University of Helsinki
ClinicalTrials.gov Identifier: NCT01705639    
Other Study ID Numbers: EudraCT-2011-005360-22
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tom Forsén, University of Helsinki:
diabetes
melatonin
glucose tolerance
sleep
Additional relevant MeSH terms:
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Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
 Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants