Completed

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

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What is being tested

Melatonin

Drug
Who is being recruted

Endocrine System Diseases+2

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

From 18 to 75 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Phase 3
Interventional
Study Start: November 2012
See protocol details

Summary

Principal SponsorUniversity of Helsinki
Last updated: January 4, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

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

NCT01705639
Principal SponsorUniversity of Helsinki
Last updated: January 4, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes Mellitus

Criteria

3 inclusion criteria required to participate
Age 18-75 years
Known genotype for MTNR1B from the Botnia-ppp study
signed informed concent
16 exclusion criteria prevent from participating
Diabetes
Positive GAD-ab
Sever dysregulated hypertension
allergy to melatonin or other substance in the capsule
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
melatonin 4mg od for 3 months

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Botniacentret Jakobstad

Jakobstad, FinlandOpen Botniacentret Jakobstad in Google Maps

Vasa health care centre

Vaasa, Finland
Completed2 Study Centers