Interaction of Melatonin With MTNR1B Genotype on Glucose... | NCT03464084

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

NCT03464084

Sponsor

Brigham and Women's Hospital

Status

Completed

Last Update Posted

Jul 26, 2022Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Glucose
Circadian Rhythm
Melatonin
Genes
Light

Interventions

placebo
melatonin
bright light
dim light

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01DK102696	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 17, 2018Actual

Primary Completion Date

Jul 19, 2022Actual

Completion Date

Jul 19, 2022Actual

First Submitted Date

Mar 2, 2018

First Submission Date that Met QC Criteria

Mar 12, 2018

First Posted Date

Mar 13, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2022

Last Update Posted Date

Jul 26, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Frank AJL Scheer, PhD, Professor of Medicine, Brigham and Women's HospitalPrincipal Investigator

Lead Sponsor

Brigham and Women's HospitalOTHER

Collaborators

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
bright light placebo	Other	Drug: placebo Other: bright light
bright light melatonin	Other	Dietary Supplement: melatonin Other: bright light
dim light	Other	Other: dim light

Interventions

Name	Type	Description	Arm Group Labels	Other Names
placebo	Drug	Capsules containing microcrystalline cellulose	bright light placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frank AJL Scheer, PhD	Brigham and Women's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital		Boston	Massachusetts	02115	United States

Intervention Browse Module

MeSH Terms

ID	Term
D008550	Melatonin

Ancestor Terms

ID	Term
D014363	Tryptamines
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided