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OpenTrials
Completed

NCT Number: NCT01705639

Melatonin and Glucose Tolerance Among Individuals With a Variant of the 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

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Glucose Tolerance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Botniacentret Jakobstad, Jakobstad, Finland

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin

Drug

All subjects receive the same dose of melatonin

Other names: Circadin

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

  • Folkhalsan Research Center
  • Lund University

Registry information

Official study title

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

Acronym: MELAG

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 12, 2012
Registry last updated
Jan 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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