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Interaction of Melatonin and MTNR1B Genotype on Glucose Control

This study is currently recruiting participants.
Verified December 2016 by Frank AJL Scheer, PhD, Brigham and Women's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02642640
First Posted: December 30, 2015
Last Update Posted: December 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Frank AJL Scheer, PhD, Brigham and Women's Hospital
  Purpose
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 Intervention
Glucose Circadian Rhythm Melatonin Genes Dietary Supplement: melatonin Drug: placebo

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Frank AJL Scheer, PhD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • change in disposition index [ Time Frame: Day 2, 3, 4 and/or 5 of the in-laboratory protocol ]
    Disposition index will be determined by frequently sampled intravenous glucose tolerance test


Secondary Outcome Measures:
  • change in first-phase insulin release [ Time Frame: Day 2, 3, 4 and/or 5 of the in-laboratory protocol ]
  • change in insulin sensitivity [ Time Frame: Day 2, 3, 4 and/or 5 of the in-laboratory protocol ]
  • change in glucose tolerance [ Time Frame: Day 2, 3, 4 and/or 5 of the in-laboratory protocol ]

Other Outcome Measures:
  • change in plasma melatonin [ Time Frame: Day 2, 3, 4 and/or 5 of the in-laboratory protocol ]
  • change in endocrine markers involved in glucose control, such as cortisol [ Time Frame: Day 2, 3, 4 and/or 5 of the in-laboratory protocol ]
  • change in measures of autonomic function such as catecholamines [ Time Frame: Day 2, 3, 4 and/or 5 of the in-laboratory protocol ]
  • change in measures of thermoregulation including core body temperature [ Time Frame: Day 2, 3, 4 and/or 5 of the in-laboratory protocol ]
  • change in measures of sleep and/or wake by EEG, such as total sleep duration [ Time Frame: Day 2, 3, 4 and/or 5 of the in-laboratory protocol ]
  • change in energy expenditure by indirect calorimetry [ Time Frame: Day 2, 3, 4 and/or 5 of the in-laboratory protocol ]
  • change in hunger and appetite ratings by visual analogue scale [ Time Frame: Day 2, 3, 4 and/or 5 of the in-laboratory protocol ]
  • change in measures of sleep and cognitive performance such as by PVT [ Time Frame: Day 2, 3, 4 and/or 5 of the in-laboratory protocol ]
  • change in blood pressure [ Time Frame: Day 2, 3, 4 and/or 5 of the in-laboratory protocol ]

Estimated Enrollment: 24
Study Start Date: November 2016
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
melatonin-placebo
subjects will receive melatonin first and placebo second
Dietary Supplement: melatonin
5 mg of melatonin per os.
Drug: placebo
placebo-melatonin
subjects will receive placebo first and melatonin second
Dietary Supplement: melatonin
5 mg of melatonin per os.
Drug: placebo

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index: 18.5 and 39.9 kg/m2
  • Age: 18-60 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
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): NCT02642640


Contacts
Contact: Frank AJL Scheer, PhD 617-732-7014 fscheer@bwh.harvard.edu
Contact: Jingyi Qian, PhD 617-525-7423 jqian5@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Sean Byrne    617-525-8655    sbyrne4@partners.org   
Contact: Jingyi Qian, PhD    617-525-7423    jqian5@partners.org   
Principal Investigator: Frank AJL Scheer, PhD         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Frank AJL Scheer, PhD Brigham and Women's Hospital
  More Information

Responsible Party: Frank AJL Scheer, PhD, Associate Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02642640     History of Changes
Other Study ID Numbers: R01DK102696 ( U.S. NIH Grant/Contract )
First Submitted: December 21, 2015
First Posted: December 30, 2015
Last Update Posted: December 12, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants