Trial Outcomes & Findings for Effects of Melatonin Supplementation on Renal Physiology in a Habitual Sleep Restricted Population. (NCT NCT02631148)
NCT ID: NCT02631148
Last Updated: 2021-06-30
Results Overview
renal specific RAAS activity will be assessed via para-aminohippurate (PAH) renal plasma flow testing with captopril
TERMINATED
PHASE2
12 participants
6 weeks
2021-06-30
Participant Flow
Recruitment via posters and online advertisement
Participants randomization status was not unblinded. All enrolled participants are included in the "melatonin arm"
Participant milestones
| Measure |
Melatonin
Circadin, controlled release melatonin tablet 2mg by mouth each day before bedtime for 6 weeks
Melatonin: 2mg controlled release melatonin tablet
|
Placebo
Placebo tablet identical to Circadin by mouth each day before bedtime for 6 weeks
Placebo: placebo tablet identical to circadin
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
0
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
0
|
Reasons for withdrawal
| Measure |
Melatonin
Circadin, controlled release melatonin tablet 2mg by mouth each day before bedtime for 6 weeks
Melatonin: 2mg controlled release melatonin tablet
|
Placebo
Placebo tablet identical to Circadin by mouth each day before bedtime for 6 weeks
Placebo: placebo tablet identical to circadin
|
|---|---|---|
|
Overall Study
8 were ineligible
|
8
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
PAH not available to study participant
|
1
|
0
|
Baseline Characteristics
Effects of Melatonin Supplementation on Renal Physiology in a Habitual Sleep Restricted Population.
Baseline characteristics by cohort
| Measure |
Melatonin
n=12 Participants
Circadin, controlled release melatonin tablet 2mg by mouth each day before bedtime for 6 weeks
Melatonin: 2mg controlled release melatonin tablet
|
Placebo
Placebo tablet identical to Circadin by mouth each day before bedtime for 6 weeks
Placebo: placebo tablet identical to circadin
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age > 18 years
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
—
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
—
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
—
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
—
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
—
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Twelve consented participants were screened. Eight were ineligible. One withdrew consent. Only two participants completed the study with blood sampling. One participant was unable to be randomized as PAH was unavailable. For the two participants who completed the study measurements were not made on the samples due to early study termination. The study was terminated due to inability to obtain PAH to perform renal specific RAAS assessments.
renal specific RAAS activity will be assessed via para-aminohippurate (PAH) renal plasma flow testing with captopril
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 weeksPopulation: Twelve consented participants were screened. Eight were ineligible. One withdrew consent. Only two participants completed the study. One participant was unable to be randomized as PAH was unavailable. For the two participants who completed the study, measurements were not completed due to early study termination. The study was terminated due to inability to obtain PAH to perform renal specific RAAS assessments.
systemic RAAS will be assessed by plasma renin activity (PRA), angiotensin II (Ang II) levels and urine aldosterone
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksPopulation: Twelve consented participants were screened. Eight were ineligible. One withdrew consent. Only two participants completed the study with blood sampling. One participant was unable to be randomized as PAH was unavailable. For the two participants who completed the study, analysis of measures were not conducted due to early study termination. The study was terminated due to inability to obtain PAH to perform renal specific RAAS assessments.
Glucose metabolism will be evaluated by applying the Oral Minimal Model method to the results of a 2 hour 7- measurement, mixed meal tolerance test. From the glucose, insulin and c-peptide measurements calculation of insulin sensitivity (reciprocal of insulin resistance) and β-cell responsivity will be calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksPopulation: Twelve consented participants were screened. Eight were ineligible. One withdrew consent. Only two participants completed the study with blood sampling. One participant was unable to be randomized as PAH was unavailable. For the two participants who completed the study, analysis of measures were not conducted due to early study termination. The study was terminated due to inability to obtain PAH to perform renal specific RAAS assessments.
Central blood pressure will be measured by pulse wave analysis using the SphygmoCor system (AtCor Medical, West Ryde, NSW, Australia), which measures central blood pressure and arterial stiffness.
Outcome measures
Outcome data not reported
Adverse Events
Melatonin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place