Trials / Completed
CompletedNCT03464084
Interaction of Melatonin With MTNR1B Genotype on Glucose Control - Study 2
Interaction of Melatonin and Light With MTNR1B Genotype on Glucose Control - Study 2
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Brigham and Women's Hospital · Academic / Other
- Sex
- All
- Age
- 21 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | placebo | Capsules containing microcrystalline cellulose |
| DIETARY_SUPPLEMENT | melatonin | 5 mg of melatonin per os. |
| OTHER | bright light | room light will be bright |
| OTHER | dim light | room light will be dim |
Timeline
- Start date
- 2018-02-17
- Primary completion
- 2022-07-19
- Completion
- 2022-07-19
- First posted
- 2018-03-13
- Last updated
- 2022-07-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03464084. Inclusion in this directory is not an endorsement.