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

Not Applicable

Completed

• Conditions: Melatonin; Circadian Rhythm; Genes; Glucose
• Interventions: Dietary Supplement: melatonin; Drug: placebo

• Registration Number: NCT02642640
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2015-12-28
• Study First Posted: 2015-12-30
• Study Start: 2016-11
• Primary Completion: 2022-03-24
• Study Completion: 2022-03-24
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-22
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Body Mass Index: 20 and 35 kg/m2
• Age: 21-55 years of age
• Caucasian
• Non-smoking
• With regular sleep-wake cycle
• Passed medical and psychological screening tests

Exclusion Criteria

• Acute, chronic or debilitating medical conditions
• History of neurological or psychiatric disorder
• History of sleep disorder or regular use of sleep-promoting medication
• Current prescription, herbal, or over-the-counter medication use
• Traveling across 2 or more time zones within past 3 months
• Worked night or rotating shift work within past 1 year
• Drug or alcohol dependency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
melatonin-placebo	melatonin	subjects will receive melatonin first and placebo second
melatonin-placebo	placebo	subjects will receive melatonin first and placebo second
placebo-melatonin	melatonin	subjects will receive placebo first and melatonin second
placebo-melatonin	placebo	subjects will receive placebo first and melatonin second

Primary Outcome Measures

Name	Time	Method
change in disposition index	Day 2 and/or 4 of the in-lab protocol	Disposition index will be determined by frequently sampled intravenous glucose tolerance test

Secondary Outcome Measures

Name	Time	Method
change in first-phase insulin release	Day 2, 3, 4 and/or 5 of the in-lab protocol
change in insulin sensitivity	Day 2, 3, 4 and/or 5 of the in-lab protocol
change in glucose tolerance	Day 2, 3, 4 and/or 5 of the in-lab protocol

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States