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

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ClinicalTrials.gov Identifier: NCT02642640
Recruitment Status : Recruiting
First Posted : December 30, 2015
Last Update Posted : March 30, 2018
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

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 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 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 MTNR1B Genotype on Glucose Control - Study 1
Study Start Date : November 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. change in disposition index [ Time Frame: 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 :
  1. change in first-phase insulin release [ Time Frame: Day 2, 3, 4 and/or 5 of the in-lab protocol ]
  2. change in insulin sensitivity [ Time Frame: Day 2, 3, 4 and/or 5 of the in-lab protocol ]
  3. change in glucose tolerance [ Time Frame: Day 2, 3, 4 and/or 5 of the in-lab protocol ]


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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

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 jqian@bwh.harvard.edu

Locations
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, PhD    617-525-7423    jqian@bwh.harvard.edu   
Principal Investigator: Frank AJL Scheer, PhD         
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

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: 2015P000857A
R01DK102696 ( U.S. NIH Grant/Contract )
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

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