Trial | NCT01705639  Report issue

Title

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?

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    melatonin ...

  • Study Participants

    45
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
http://www.sciencedirect.com/science/article/pii/S1550413116301607
Study Started
Nov 30
2012
Primary Completion
Aug 31
2014
Study Completion
Aug 31
2014
Last Update
Jan 04
2017
Estimate

Drug Melatonin

All subjects receive the same dose of melatonin

  • Other names: Circadin

Melatonin Experimental

melatonin 4mg od for 3 months

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
No Results Posted