An interventional study of placebo and melatonin in Glucose, Circadian Rhythm and Melatonin, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-26.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Basic science
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.
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.
Brigham and Women's Hospital is the lead sponsor of 1,263 studies on the registry; 225 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
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Exclusion Criteria:
Drug: placebo · Other: bright light
Dietary Supplement: melatonin · Other: bright light
Other: dim light
Capsules containing microcrystalline cellulose
5 mg of melatonin per os.
room light will be bright
room light will be dim
change in glucose tolerance
glucose responses to test meal compared across the three in-lab protocols
Time frame: Day 1 of the three in-lab protocols
change in first-phase insulin release
insulin responses to test meal compared across the three in-lab protocols
Time frame: Day 1 of the three in-lab protocols
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Melatonin
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