ClinicalTrials.Veeva

Menu

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

Mass General Brigham logo

Mass General Brigham

Status

Completed

Conditions

Circadian Rhythm
Genes
Glucose
Melatonin

Treatments

Dietary Supplement: melatonin
Drug: placebo

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02642640
R01DK102696 (U.S. NIH Grant/Contract)
2015P000857A

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

21 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

20 participants in 2 patient groups

melatonin-placebo
Other group
Description:
subjects will receive melatonin first and placebo second
Treatment:
Drug: placebo
Dietary Supplement: melatonin
placebo-melatonin
Other group
Description:
subjects will receive placebo first and melatonin second
Treatment:
Drug: placebo
Dietary Supplement: melatonin

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems