NCT02642640

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
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

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

First Submitted

Initial submission to the registry

December 21, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2022

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

February 12, 2026

Completed
Last Updated

February 12, 2026

Status Verified

January 1, 2026

Enrollment Period

5.4 years

First QC Date

December 21, 2015

Results QC Date

October 22, 2025

Last Update Submit

January 26, 2026

Conditions

GlucoseCircadian RhythmMelatoninGenes

Outcome Measures

Primary Outcomes (1)

  • Disposition Index

    Disposition index is determined by frequently sampled intravenous glucose tolerance test. It is a composite measure of β-cell function adjusted for insulin sensitivity-was calculated as the product of insulin sensitivity and insulin secretion indices. High value means stronger β-cell function. Theoretical minimum is 0, no theoretical maximum.

    During frequently sampled intravenous glucose tolerance test after melatonin/placebo administration on Day 2/4 (melatonin/placebo order randomized) in the laboratory visit

Secondary Outcomes (3)

  • First-phase Beta-cell Responsivity

    During frequently sampled intravenous glucose tolerance test after melatonin/placebo administration on Day 2/4 (melatonin/placebo order randomized) in the laboratory visit

  • Insulin Sensitivity

    During frequently sampled intravenous glucose tolerance test after melatonin/placebo administration on Day 2/4 (melatonin/placebo order randomized) in the laboratory visit

  • Glucose Tolerance

    During frequently sampled intravenous glucose tolerance test after melatonin/placebo administration on Day 2/4 (melatonin/placebo order randomized) in the laboratory visit

Study Arms (2)

melatonin-placebo

OTHER

subjects will receive melatonin first and placebo second

Dietary Supplement: melatoninDrug: placebo

placebo-melatonin

OTHER

subjects will receive placebo first and melatonin second

Dietary Supplement: melatoninDrug: placebo

Interventions

melatoninDIETARY_SUPPLEMENT

5 mg of melatonin per os.

melatonin-placeboplacebo-melatonin
placeboDRUG
melatonin-placeboplacebo-melatonin

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

Results Point of Contact

Title
Frank AJL Scheer, Ph.D.
Organization
Brigham and Women's Hospital
fscheer@mgb.org
617-732-7014

Study Officials

  • Frank AJL Scheer, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

December 21, 2015

First Posted

December 30, 2015

Study Start

November 1, 2016

Primary Completion

March 24, 2022

Study Completion

March 24, 2022

Last Updated

February 12, 2026

Results First Posted

February 12, 2026

Record last verified: 2026-01

Locations

US(1)