NCT03464084

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2022

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

4.4 years

First QC Date

March 2, 2018

Last Update Submit

July 22, 2022

Conditions

GlucoseCircadian RhythmMelatoninGenesLight

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • change in first-phase insulin release

    Day 1 of the three in-lab protocols

Study Arms (3)

bright light placebo

OTHER
Drug: placeboOther: bright light

bright light melatonin

OTHER
Dietary Supplement: melatoninOther: bright light

dim light

OTHER
Other: dim light

Interventions

placeboDRUG

Capsules containing microcrystalline cellulose

bright light placebo
melatoninDIETARY_SUPPLEMENT

5 mg of melatonin per os.

bright light melatonin
bright lightOTHER

room light will be bright

bright light melatoninbright light placebo
dim lightOTHER

room light will be dim

dim light

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Frank AJL Scheer, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

March 2, 2018

First Posted

March 13, 2018

Study Start

February 17, 2018

Primary Completion

July 19, 2022

Study Completion

July 19, 2022

Last Updated

July 26, 2022

Record last verified: 2022-07

Locations

US(1)