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

Diabetes Clinical Trial

— MELAG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01705639
• Other study ID #: EudraCT-2011-005360-22
• Status: Completed
• Phase: Phase 3
• First received: October 10, 2012
• Last updated: January 3, 2017
• Start date: November 2012
• Est. completion date: August 2014

Study information

• Verified date: January 2017
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes
• Glucose Tolerance

Intervention

Drug:
• Melatonin
All subjects receive the same dose of melatonin

Locations

Country	Name	City	State
Finland	Botniacentret Jakobstad	Jakobstad
Finland	Vasa health care centre	Vasa

Sponsors (3)

Lead Sponsor	Collaborator
Helsinki University	Folkhalsan Research Center, Lund University

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Tuomi T, Nagorny CL, Singh P, Bennet H, Yu Q, Alenkvist I, Isomaa B, Östman B, Söderström J, Pesonen AK, Martikainen S, Räikkönen K, Forsén T, Hakaste L, Almgren P, Storm P, Asplund O, Shcherbina L, Fex M, Fadista J, Tengholm A, Wierup N, Groop L, Mulder — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose tolerance	Glucose tolerance is measured in OGTT: 0,30,60,90 and 120 minute values of glucose and insulin.	3 months	No
Secondary	sleep	monitoring of sleep with questionnaires and activity monitoring	3 months	No
Secondary	Activity	Activity and sleep of the subjects is recorded with Actigraph at 0 and 3 months	3 months	No

External Links

•   Publication