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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-08-31

Brief Summary

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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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Detailed Description

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

Conditions

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Diabetes Glucose Tolerance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Melatonin

melatonin 4mg od for 3 months

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

All subjects receive the same dose of melatonin

Interventions

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Melatonin

All subjects receive the same dose of melatonin

Intervention Type DRUG

Other Intervention Names

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Circadin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes