Melatonin and the Metabolic Syndrome (MetSyn)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01038921
Recruitment Status : Completed
First Posted : December 24, 2009
Results First Posted : May 1, 2014
Last Update Posted : February 27, 2015
Information provided by (Responsible Party):
Michael Kutner, Emory University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Metabolic Syndrome
Interventions: Drug: Melatonin
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One week run in period on placebo. Six week washout period between crossover.

Reporting Groups
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

Participant Flow:   Overall Study
    Melatonin   Placebo
STARTED   19 [1]   20 [2] 
COMPLETED   17 [3]   20 
Withdrawal by Subject                1                0 
Physician Decision                1                0 
[1] 19 subjects received melatonin first(10 weeks), washout (6 weeks), placebo second (10 weeks)
[2] 20 subjects received placebo first (10 weeks), washout (6 weeks), melatonin second ( 10 weeks)
[3] 2 subjects withdrew

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Expected to enroll 40 subjects but only randomized 39 subjects

Reporting Groups
Melatonin First Cross-over design with subjects receiving Melatonin First
Placebo First Cross-over design with subjects receiving Placebo First
Total Total of all reporting groups

Baseline Measures
   Melatonin First   Placebo First   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   20   39 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   15   18   33 
>=65 years   4   2   6 
[Units: Years]
Mean (Standard Deviation)
 62.7  (9.6)   57.6  (10.1)   58.9  (10.4) 
[Units: Participants]
Female   9   8   17 
Male   10   12   22 
Race (NIH/OMB) [1] 
[Units: Participants]
American Indian or Alaska Native   0   0   0 
Asian   0   1   1 
Native Hawaiian or Other Pacific Islander   0   1   1 
Black or African American   6   7   13 
White   13   11   24 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
[1] Melatonin First Placebo First Caucasian 13 11 African American 6 7 Other 0 2
Region of Enrollment 
[Units: Participants]
United States   19   20   39 

  Outcome Measures

1.  Primary:   Metabolic Syndrome Components   [ Time Frame: 3 years ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was designed as a pilot Phase II cross-over design to study the safety of melatonin and to estimate the effect sizes associated with average changes while subjects were on melatonin versus average changes while subjects were on placebo.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Abinav Goyal
Organization: Emory University
phone: 404-727-8758

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Michael Kutner, Emory University Identifier: NCT01038921     History of Changes
Other Study ID Numbers: IRB00014784
R21AT004220-01A2 ( U.S. NIH Grant/Contract )
First Submitted: December 22, 2009
First Posted: December 24, 2009
Results First Submitted: August 13, 2013
Results First Posted: May 1, 2014
Last Update Posted: February 27, 2015