Glucose, Circadian Rhythm, Melatonin, Genes, Light
Conditions
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.
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.
Interventions
DRUGplacebo
Capsules containing microcrystalline cellulose
DIETARY_SUPPLEMENTmelatonin
5 mg of melatonin per os.
OTHERbright light
room light will be bright
OTHERdim light
room light will be dim
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in glucose tolerance | Day 1 of the three in-lab protocols | glucose responses to test meal compared across the three in-lab protocols |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in first-phase insulin release | Day 1 of the three in-lab protocols | insulin responses to test meal compared across the three in-lab protocols |
Countries
United States
Outcome results
None listed