NCT01705639

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Nov 2012

Typical duration for phase_3 diabetes

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2012

Completed
20 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

1.7 years

First QC Date

October 10, 2012

Last Update Submit

January 3, 2017

Conditions

DiabetesGlucose Tolerance

Keywords

diabetesmelatoninglucose tolerancesleep

Outcome Measures

Primary Outcomes (1)

  • Glucose tolerance

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

    3 months

Secondary Outcomes (2)

  • sleep

    3 months

  • Activity

    3 months

Study Arms (1)

Melatonin

EXPERIMENTAL

melatonin 4mg od for 3 months

Drug: Melatonin

Interventions

MelatoninDRUG

All subjects receive the same dose of melatonin

Also known as: Circadin
Melatonin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • signed informed concent
  • Known genotype for MTNR1B from the Botnia-ppp study
  • Age 18-75 years

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Botniacentret Jakobstad

Jakobstad, 68660, Finland

Location

Vasa health care centre

Vaasa, 65200, Finland

Location

Related Publications (1)

  • Tuomi T, Nagorny CLF, Singh P, Bennet H, Yu Q, Alenkvist I, Isomaa B, Ostman B, Soderstrom J, Pesonen AK, Martikainen S, Raikkonen K, Forsen T, Hakaste L, Almgren P, Storm P, Asplund O, Shcherbina L, Fex M, Fadista J, Tengholm A, Wierup N, Groop L, Mulder H. Increased Melatonin Signaling Is a Risk Factor for Type 2 Diabetes. Cell Metab. 2016 Jun 14;23(6):1067-1077. doi: 10.1016/j.cmet.2016.04.009. Epub 2016 May 12.

    PMID: 27185156RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Leif Groop, Prof.

    University of Lund, University of Helsinki

    STUDY CHAIR

  • Tiinamaija Tuomi, Docent

    Helsinki University Central Hospital

    STUDY DIRECTOR

  • Bo Isomaa, Docent

    Folkhalsan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

October 10, 2012

First Posted

October 12, 2012

Study Start

November 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

January 4, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

FI(2)