GlucoseNCT03464084
Interaction of Melatonin With MTNR1B Genotype on Glucose Control - Study 2
A study testing melatonin, bright light and dim light in people with Glucose and Circadian Rhythm, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose, Circadian Rhythm, Melatonin
- What is being tested?
- melatonin, bright light and dim light
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2018to 19 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Interaction of Melatonin and Light With MTNR1B Genotype on Glucose Control - Study 2
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Capsules containing microcrystalline cellulose
melatoninDietary supplement
5 mg of melatonin per os.
bright lightOther
room light will be bright
dim lightOther
room light will be dim
| Study group | Role | What they receive |
|---|---|---|
| bright light placebo | Other | Not described Receives: Drug: placebo; Other: bright light |
| bright light melatonin | Other | Not described Receives: Dietary Supplement: melatonin; Other: bright light |
| dim light | Other | Not described Receives: Other: dim light |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in glucose tolerance
glucose responses to test meal compared across the three in-lab protocols
Measured: Day 1 of the three in-lab protocols
Secondary outcomes (1)
change in first-phase insulin release
insulin responses to test meal compared across the three in-lab protocols
Measured: Day 1 of the three in-lab protocols
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start17 Feb 2018
- Primary completion19 Jul 2022
- Study completion19 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlucoseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank AJL Scheer, PhD, Brigham and Women's Hospital
- Investigators
- Frank AJL Scheer, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464084
- Sponsor's protocol ID
- 2015P000857B
- Other IDs
- R01DK102696
- Status last verified
- Jul 2022
- First submitted
- 2 Mar 2018
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction of Melatonin and Light With MTNR1B Genotype on Glucose Control - Study 2
- ClinicalTrials.gov ID
- NCT03464084
- Acronym / sponsor ID
- 2015P000857B
- Conditions
- Glucose, Circadian Rhythm, Melatonin, Genes, Light
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 17 Feb 2018 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Body Mass Index: 20 and 35 kg/m2
- Age: 21-55 years of age
- Caucasian
- Non-smoking
- With regular sleep-wake cycle
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboCapsules containing microcrystalline cellulose | Drug | bright light placebo |
| melatonin5 mg of melatonin per os. | Dietary supplement | bright light melatonin |
| bright lightroom light will be bright | Other | bright light melatonin, bright light placebo |
| dim lightroom light will be dim | Other | dim light |
Primary outcome
change in glucose tolerance
Time frame: Day 1 of the three in-lab protocols
glucose responses to test meal compared across the three in-lab protocols
1 secondary outcome
change in first-phase insulin release
Time frame: Day 1 of the three in-lab protocols
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank AJL Scheer, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing melatonin, bright light and dim light in people with Glucose and Circadian Rhythm, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in glucose tolerance (time frame: Day 1 of the three in-lab protocols). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.