Interaction of Melatonin With MTNR1B Genotype on Glucose Control - Study 2

Circadian Rhythm Clinical Trial

Official title:

Interaction of Melatonin and Light With MTNR1B Genotype on Glucose Control - Study 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464084
• Other study ID #: 2015P000857B
• Secondary ID: R01DK102696
• Status: Completed
• Phase: N/A
• Start date: February 17, 2018
• Est. completion date: July 19, 2022

Study information

• Verified date: July 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• 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: 24
• Est. completion date: July 19, 2022
• Est. primary completion date: July 19, 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

Related Conditions & MeSH terms

• Circadian Rhythm
• Genes
• Glucose
• Light
• Melatonin

Intervention

Drug:
• placebo
Capsules containing microcrystalline cellulose

Dietary Supplement:
• melatonin
5 mg of melatonin per os.

Other:
• bright light
room light will be bright
• dim light
room light will be dim

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 glucose tolerance	glucose responses to test meal compared across the three in-lab protocols	Day 1 of the three in-lab protocols
Secondary	change in first-phase insulin release	insulin responses to test meal compared across the three in-lab protocols	Day 1 of the three in-lab protocols