Interaction of Melatonin With MTNR1B Genotype on Glucose Control - Study 2

July 22, 2022 updated by: Frank AJL Scheer, PhD, Brigham and Women's Hospital

Interaction of Melatonin and Light With MTNR1B Genotype on Glucose Control - Study 2

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: bright light placebo
Drug: placebo
Capsules containing microcrystalline cellulose
Other: bright light
room light will be bright
Other: bright light melatonin
Dietary supplement: melatonin
5 mg of melatonin per os.
Other: bright light
room light will be bright
Other: dim light
Other: dim light
room light will be dim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in glucose tolerance
Time Frame: Day 1 of the three in-lab protocols
glucose responses to test meal compared across the three in-lab protocols
Day 1 of the three in-lab protocols

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in first-phase insulin release
Time Frame: Day 1 of the three in-lab protocols
insulin responses to test meal compared across the three in-lab protocols
Day 1 of the three in-lab protocols

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

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

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2018

Primary Completion (Actual)

July 19, 2022

Study Completion (Actual)

July 19, 2022

Study Registration Dates

First Submitted

March 2, 2018

First Submitted That Met QC Criteria

March 12, 2018

First Posted (Actual)

March 13, 2018

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015P000857B
  • R01DK102696 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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