N/A
N=23
Interaction of Melatonin and MTNR1B Genotype on Glucose Control - Study 1
Glucose · Circadian Rhythm · Melatonin · Genes
Bottom Line
View on ClinicalTrials.gov: NCT02642640 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Disposition Index — 1314.7; 984.5 index
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- melatonin (Dietary_supplement); placebo (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disposition Index |
1314.7; 984.5 | — |
| SECONDARY First-phase Beta-cell Responsivity |
118.3; 88.9 | — |
| SECONDARY Insulin Sensitivity |
4.7; 3.7 | — |
| SECONDARY Glucose Tolerance |
322.6; 329.4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02642640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.