Interaction of Melatonin and MTNR1B Genotype on Glucose Control - Study 1

Circadian Rhythm Clinical Trial

Official title:

Interaction of Melatonin and MTNR1B Genotype on Glucose Control - Study 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02642640
• Other study ID #: 2015P000857A
• Secondary ID: R01DK102696
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Circadian Rhythm
• Genes
• Glucose
• Melatonin

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