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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02642640
Other study ID # 2015P000857A
Secondary ID R01DK102696
Status Completed
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date March 24, 2022

Study information

Verified date July 2022
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 24, 2022
Est. primary completion date March 24, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
melatonin
5 mg of melatonin per os.
Drug:
placebo


Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Brigham and Women's Hospital National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in disposition index Disposition index will be determined by frequently sampled intravenous glucose tolerance test Day 2 and/or 4 of the in-lab protocol
Secondary change in first-phase insulin release Day 2, 3, 4 and/or 5 of the in-lab protocol
Secondary change in insulin sensitivity Day 2, 3, 4 and/or 5 of the in-lab protocol
Secondary change in glucose tolerance Day 2, 3, 4 and/or 5 of the in-lab protocol
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