Clinical Trials Directory

Trials / Completed

CompletedNCT02642640

Interaction of Melatonin and MTNR1B Genotype on Glucose Control - Study 1

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
23 (actual)
Sponsor
Brigham and Women's Hospital · Academic / Other
Sex
All
Age
21 Years – 55 Years
Healthy volunteers
Accepted

Summary

This project aims to test the impact of melatonin and MTNR1B variation on regulation glucose regulation in a highly controlled in-laboratory setting and ex vivo in pancreatic islets.

Detailed description

The investigators' recent GWAS discovery of MTNR1B as a novel type 2 diabetes gene has sparked great interest into the role of melatonin in glycemic control, for which the mechanism is largely unknown. This research will determine the effect of melatonin and MTNR1B on glycemic control under highly-controlled, in-laboratory protocols while manipulating circulating melatonin concentrations (both up and down) and assessing glycemic control by frequently-sampled intravenous glucose tolerance tests, as well as in ex vivo human pancreatic islets. This research will provide mechanistic insights into the metabolic effects of melatonin and the MTNR1B risk variant and may help in evidence-based approaches and personalized recommendations to improve glycemic control in night shift workers and late-night eaters.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTmelatonin5 mg of melatonin per os.
DRUGplacebo

Timeline

Start date
2016-11-01
Primary completion
2022-03-24
Completion
2022-03-24
First posted
2015-12-30
Last updated
2026-02-12
Results posted
2026-02-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02642640. Inclusion in this directory is not an endorsement.