Trial Outcomes & Findings for Melatonin and the Metabolic Syndrome (NCT NCT01038921)

NCT ID: NCT01038921

Last Updated: 2015-02-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 39 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2015-02-27

Participant Flow

Recruitment period from 05/24/2010 through 12/15/2011. Recruitment was from subjects from the "Screening for Impaired Glucose Tolerance: Glucose Challenge versus Predictive Model NIH study R18DK066204,from Preventive Cardiology Clinic at Emory University Clinic and from advertisements placed on the campus of the Emory Clinic

One week run in period on placebo. Six week washout period between crossover.

Participant milestones

Measure	Melatonin Cross-over design with subject receiving either Melatonin First and Placebo Second or Placebo First and Melatonin Second	Placebo Cross-over design with subjects receiving either Placebo First and Melatonin Second or Melatonin First and Placebo Second
Overall Study STARTED	19	20
Overall Study COMPLETED	17	20
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Melatonin Cross-over design with subject receiving either Melatonin First and Placebo Second or Placebo First and Melatonin Second	Placebo Cross-over design with subjects receiving either Placebo First and Melatonin Second or Melatonin First and Placebo Second
Overall Study Withdrawal by Subject	1	0
Overall Study Physician Decision	1	0

Baseline Characteristics

Melatonin and the Metabolic Syndrome

Baseline characteristics by cohort

Measure	Melatonin First n=19 Participants Cross-over design with subjects receiving Melatonin First	Placebo First n=20 Participants Cross-over design with subjects receiving Placebo First	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	62.7 years STANDARD_DEVIATION 9.6 • n=5 Participants	57.6 years STANDARD_DEVIATION 10.1 • n=7 Participants	58.9 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	20 participants n=7 Participants	39 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Outcome measures

Measure	Melatonin n=37 Participants Cross-over design for subjects on Melatonin for 10 weeks measured at baseline and 10 weeks	Placebo n=39 Participants Cross-over design for all subjects on Placebo for 10 weeks measured at baseline and at 10 weeks.
Metabolic Syndrome Components	-2.7 mmHg Standard Deviation 11.3	4.7 mmHg Standard Deviation 13.8

Adverse Events

Melatonin First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo First

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Melatonin First n=19 participants at risk Cross-over design for subjects randomized to Melatonin First, Placebo Second	Placebo First n=20 participants at risk Cross-over design for subjects randomized to Placebo First, Melatonin Second
Cardiac disorders Mild stroke	0.00% 0/19 • 1 year	5.0% 1/20 • Number of events 1 • 1 year

Other adverse events

Adverse event data not reported

Additional Information

Dr. Abinav Goyal

Emory University

Phone: 404-727-8758

Email: agoyal4@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place