Melatonin and the Metabolic Syndrome (MetSyn)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Kutner, Emory University
ClinicalTrials.gov Identifier:
NCT01038921
First received: December 22, 2009
Last updated: May 22, 2014
Last verified: May 2014
Results First Received: August 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Metabolic Syndrome
Interventions: Drug: Melatonin
Drug: Placebo

  Participant Flow
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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
  Description
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  
NOT COMPLETED     2     0  
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
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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
  Description
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  
Number of Participants  
[units: participants]
  19     20     39  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     15     18     33  
>=65 years     4     2     6  
Age  
[units: years]
Mean ± Standard Deviation
  62.7  ± 9.6     57.6  ± 10.1     58.9  ± 10.4  
Gender  
[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  
Region of Enrollment  
[units: participants]
     
United States     19     20     39  
[1] Melatonin First Placebo First Caucasian 13 11 African American 6 7 Other 0 2



  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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
e-mail: agoyal4@emory.edu


No publications provided


Responsible Party: Michael Kutner, Emory University
ClinicalTrials.gov Identifier: NCT01038921     History of Changes
Other Study ID Numbers: IRB00014784, R21 AT 004220-01A2
Study First Received: December 22, 2009
Results First Received: August 13, 2013
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration