Trial Outcomes & Findings for Interaction of Melatonin and MTNR1B Genotype on Glucose Control - Study 1 (NCT NCT02642640)
NCT ID: NCT02642640
Last Updated: 2026-02-12
Results Overview
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.
COMPLETED
NA
23 participants
During frequently sampled intravenous glucose tolerance test after melatonin/placebo administration on Day 2/4 (melatonin/placebo order randomized) in the laboratory visit
2026-02-12
Participant Flow
Ambulatory phase (2/3 weeks), in which participants follow a self-selected Sleep-Wake cycle as well as eat pre-prepared, standardized meals for 3 days leading into the 5-day in-lab stay.
Participant milestones
| Measure |
Placebo-melatonin
subjects will receive placebo first and melatonin second
|
Melatonin-placebo
subjects will receive melatonin first and placebo second
|
|---|---|---|
|
Pre-in-lab phase
STARTED
|
12
|
11
|
|
Pre-in-lab phase
COMPLETED
|
12
|
11
|
|
Pre-in-lab phase
NOT COMPLETED
|
0
|
0
|
|
Intervention 1
STARTED
|
12
|
11
|
|
Intervention 1
COMPLETED
|
11
|
11
|
|
Intervention 1
NOT COMPLETED
|
1
|
0
|
|
Washout
STARTED
|
11
|
11
|
|
Washout
COMPLETED
|
11
|
11
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Intervention 2
STARTED
|
11
|
11
|
|
Intervention 2
COMPLETED
|
11
|
10
|
|
Intervention 2
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Interaction of Melatonin and MTNR1B Genotype on Glucose Control - Study 1
Baseline characteristics by cohort
| Measure |
All Study Participants
n=21 Participants
All participants were randomized to receive all interventions, so all participants are combined into one Group "All Study Participants".
|
|---|---|
|
Age, Continuous
|
30.1 years
STANDARD_DEVIATION 10.1 • n=41 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
HbA1c
|
5.2 %
STANDARD_DEVIATION 0.28 • n=41 Participants
|
PRIMARY outcome
Timeframe: During frequently sampled intravenous glucose tolerance test after melatonin/placebo administration on Day 2/4 (melatonin/placebo order randomized) in the laboratory visitPopulation: 1 participant excluded at melatonin treatment because of a technical difficulty during one of the frequently sampled intravenous glucose tolerance tests
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.
Outcome measures
| Measure |
Placebo
n=21 Participants
Placebo oral administration
|
Melatonin
n=20 Participants
Melatonin oral administration
|
|---|---|---|
|
Disposition Index
|
1314.7 index
Interval 1012.6 to 1707.0
|
984.5 index
Interval 687.0 to 1410.8
|
SECONDARY outcome
Timeframe: During frequently sampled intravenous glucose tolerance test after melatonin/placebo administration on Day 2/4 (melatonin/placebo order randomized) in the laboratory visitFirst-phase beta-cell responsivity to glucose is determined by frequently sampled intravenous glucose tolerance test. It likely represents exocytosis of previously primed and docked insulin secretory granules (commonly called the readily releasable pool). It is given by the ratio between the incremental amount of C-peptide secreted during the first phase and the maximum increment of the plasma glucose concentration.High value means stronger β-cell responsivity. Theoretical minimum is 0, no theoretical maximum.
Outcome measures
| Measure |
Placebo
n=21 Participants
Placebo oral administration
|
Melatonin
n=21 Participants
Melatonin oral administration
|
|---|---|---|
|
First-phase Beta-cell Responsivity
|
118.3 index
Interval 98.3 to 142.4
|
88.9 index
Interval 75.4 to 104.9
|
SECONDARY outcome
Timeframe: During frequently sampled intravenous glucose tolerance test after melatonin/placebo administration on Day 2/4 (melatonin/placebo order randomized) in the laboratory visitPopulation: 1 participant excluded at melatonin treatment because of a technical difficulty during one of the frequently sampled intravenous glucose tolerance tests
Insulin sensitivity is determined by frequently sampled intravenous glucose tolerance test. It is defined in quantitative terms as the effect of insulin to catalyse the disappearance of glucose from plasma.High value indicates better insulin sensitivity. Theoretical minimum is 0, no theoretical maximum.
Outcome measures
| Measure |
Placebo
n=21 Participants
Placebo oral administration
|
Melatonin
n=20 Participants
Melatonin oral administration
|
|---|---|---|
|
Insulin Sensitivity
|
4.7 [(mu/l)^-1.min^-1]
Interval 3.7 to 5.8
|
3.7 [(mu/l)^-1.min^-1]
Interval 2.5 to 5.3
|
SECONDARY outcome
Timeframe: During frequently sampled intravenous glucose tolerance test after melatonin/placebo administration on Day 2/4 (melatonin/placebo order randomized) in the laboratory visitPopulation: 1 participant excluded at melatonin treatment because of a technical difficulty during one of the frequently sampled intravenous glucose tolerance tests
glucose 3-hour incremental AUC during frequently sampled intravenous glucose tolerance test. High value indicates higher glucose level during the test, which is bad. Theoretical minimum is 0, no theoretical maximum.
Outcome measures
| Measure |
Placebo
n=21 Participants
Placebo oral administration
|
Melatonin
n=20 Participants
Melatonin oral administration
|
|---|---|---|
|
Glucose Tolerance
|
322.6 [mmol/l.min]
95% Confidence Interval 24.7 • Interval 296.5 to 350.9
|
329.4 [mmol/l.min]
95% Confidence Interval 12.7 • Interval 302.9 to 358.2
|
Adverse Events
All Intervention Combined
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Intervention Combined
n=23 participants at risk
Placebo or Melatonin oral administration on Day 2 or Day 4 of their in-laboratory stay (order randomized)
|
|---|---|
|
General disorders
Nausea
|
4.3%
1/23 • From admission to the in-laboratory until the discharge from the laboratory, up to 5 days
Adverse events were reported with both interventions combined. This is because the adverse events happened either before any intervention started or after both ended, it is hard to attribute the events to one specific intervention.
|
|
Surgical and medical procedures
Failed attempts to place IV lines
|
4.3%
1/23 • Number of events 1 • From admission to the in-laboratory until the discharge from the laboratory, up to 5 days
Adverse events were reported with both interventions combined. This is because the adverse events happened either before any intervention started or after both ended, it is hard to attribute the events to one specific intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place