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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01705639

Acronym

MELAG

Enrollment

Registered

2012-10-12

Start date

2012-11-30

Completion date

2014-08-31

Last updated

2017-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Glucose Tolerance

Keywords

diabetes, melatonin, glucose tolerance, sleep

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

Detailed description

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

Interventions

DRUGMelatonin

All subjects receive the same dose of melatonin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026