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Completed

NCT Number: NCT03464084

Interaction of Melatonin 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.

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Key information

Conditions

Glucose Circadian Rhythm Genes Light Melatonin

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Capsules containing microcrystalline cellulose

melatonin

Dietary Supplement

5 mg of melatonin per os.

bright light

Other

room light will be bright

Dim Light

Other

room light will be dim

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 13, 2018
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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