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

Phase 3

Completed

• Conditions: Diabetes; Glucose Tolerance
• Interventions: Drug: Melatonin

• Registration Number: NCT01705639
• Lead Sponsor: University of Helsinki

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

Study Timeline

• Study First Submitted: 2012-10-10
• Study First Submitted QC: 2012-10-11
• Study First Posted: 2012-10-12
• Study Start: 2012-11
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Melatonin	Melatonin	melatonin 4mg od for 3 months

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Vasa health care centre; 🇫🇮 Vasa, Finland

Botniacentret Jakobstad; 🇫🇮 Jakobstad, Finland