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

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ClinicalTrials.gov Identifier: NCT03464084
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : March 29, 2021
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Frank AJL Scheer, PhD, Brigham and Women's Hospital

Study Description
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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 Light Drug: placebo Dietary Supplement: melatonin Other: bright light Other: dim light Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Interaction of Melatonin and Light With MTNR1B Genotype on Glucose Control - Study 2
Actual Study Start Date : February 17, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arms and Interventions
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Arm Intervention/treatment
bright light placebo Drug: placebo
Capsules containing microcrystalline cellulose

Other: bright light
room light will be bright
bright light melatonin Dietary Supplement: melatonin
5 mg of melatonin per os.

Other: bright light
room light will be bright
dim light Other: dim light
room light will be dim


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03464084


Contacts
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Contact: Frank AJL Scheer, PhD 6177327014 fscheer@bwh.harvard.edu
Contact: Jingyi Qian, PhD 6175257423 jqian@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lauren Kelly    617-278-0662    lkelly17@bwh.harvard.edu   
Contact: Jingyi Qian    6175257423    jqian@bwh.harvard.edu   
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Frank AJL Scheer, PhD Brigham and Women's Hospital
More Information
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Responsible Party: Frank AJL Scheer, PhD, Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03464084    
Other Study ID Numbers: 2015P000857B
R01DK102696 ( U.S. NIH Grant/Contract )
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
 Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants