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

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02642640

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Enrollment

Location

Arms

64.7

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glucose Circadian Rhythm Melatonin Genes	Dietary Supplement: melatonin Drug: placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Mar 24, 2022

Actual Study Completion Date :

Mar 24, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: melatonin-placebo subjects will receive melatonin first and placebo second	Dietary Supplement: melatonin 5 mg of melatonin per os. Drug: placebo
Other: placebo-melatonin subjects will receive placebo first and melatonin second	Dietary Supplement: melatonin 5 mg of melatonin per os. Drug: placebo

Arm

Intervention/Treatment

Other: melatonin-placebo

subjects will receive melatonin first and placebo second

Dietary Supplement: melatonin

5 mg of melatonin per os.

Drug: placebo

Other: placebo-melatonin

subjects will receive placebo first and melatonin second

Dietary Supplement: melatonin

5 mg of melatonin per os.

Drug: placebo

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

Brigham and Women's Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator: Frank AJL Scheer, PhD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Frank AJL Scheer, PhD, Professor of Medicine, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT02642640

Other Study ID Numbers:

2015P000857A
R01DK102696

First Posted:

Dec 30, 2015

Last Update Posted:

Jul 26, 2022

Last Verified:

Jul 1, 2022

Additional relevant MeSH terms:

Melatonin

Study Results

No Results Posted as of Jul 26, 2022