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

University of Helsinki

Status and phase: Completed; Phase 3

Conditions: Diabetes; Glucose Tolerance

Treatments: Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT01705639

EudraCT-2011-005360-22

Details and patient eligibility

About

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

Full description

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

Enrollment: 45 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Melatonin

Experimental group

Description:

melatonin 4mg od for 3 months

Treatment:

Drug: Melatonin