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Metabolic Effects of Melatonin Treatment

NCT03859934 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-08-25

No results posted yet for this study

Summary

Modern living is associated with an epidemic of type 2 diabetes mellitus (T2DM). Sleep disturbances such as insomnia or frequent awakenings are strong risk factors for T2DM with several studies indicating a central role of melatonin. Additionally, a certain single nucleotide polymorphism in the melatonin receptor gene, MTNR1B rs10830963, with an allele frequency of 30 %, is associated with increased fasting plasma glucose and T2DM. Due to treatment of, among other things, insomnia, the use of melatonin is increasing rapidly in Denmark with a 100-fold increase from 2007-2012 in children and adolescents. No previous studies have thoroughly assessed changes in glucose and fatty acid metabolism after 3 months of melatonin treatment in patients with T2DM.

Conditions

Interventions

DRUG

Melatonin

Melatonin treatment

DRUG

Placebo Oral Tablet

Placebo treatment

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Esben Stistrup Lauritzen, MD · Medical Research Laboratory

  • Ulla Kampmann Opstrup, MD, PhD · Aarhus University Hospital

  • Julie Støy, MD, PhD · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-26
Primary Completion
2021-05-03
Completion
2021-08-18

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03859934 on ClinicalTrials.gov