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

December 22, 2009
May 22, 2014
July 2009
June 2012   (final data collection date for primary outcome measure)
Metabolic Syndrome Components [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01038921 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Melatonin and the Metabolic Syndrome
Melatonin Supplementation and the Metabolic Syndrome: A Phase II Crossover Design Clinical Trial

This trial seeks to compare the effects of melatonin supplementation versus placebo in subjects with the metabolic syndrome.

The primary purpose of this Phase II crossover design trial is to examine the safety and efficacy of 8mg of melatonin taken one hour before bedtime compared to a placebo treatment to improve at least one of the five components associated with the metabolic syndrome.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Metabolic Syndrome
  • Drug: Melatonin
    8 mg dose of Melatonin
  • Drug: Placebo
    Placebo
  • Experimental: Melatonin
    Melatonin 8mg one hour before bedtime for 10 weeks
    Intervention: Drug: Melatonin
  • Placebo Comparator: Placebo
    Placebo administered 1 hour before bedtime for 10 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
July 2013
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 30-79 years.
  2. Diagnosed with metabolic syndrome according to AdenosineTriphosphate-III criteria.
  3. Availability for six months after enrolling in the study.

Exclusion Criteria:

  1. Inability to understand informed consent and to cooperate with study procedures.
  2. Supplemental intake of melatonin.
  3. Current smoking.
  4. Current use of calcium channel blockers.
  5. Current, planned, or recent (12 months) participation in another clinical trial.
  6. Women who are pregnant, breast-feeding, attempting conception, or planning to attempt conception over the next 6 months.
  7. Presence of any of the following diagnosed health conditions:

    • Active malignancy other than nonmelanoma skin cancer (current therapy for this malignancy,diagnosis within five years of enrollment, recurrence within five years of enrollment, or metastasis)
    • Uncontrolled hypothyroidism or hyperthyroidism
    • Recent (< 1 year ago) history of heart attack, bypass surgery, angioplasty, or stroke
    • Heart failure (New York Heart Association functional class 3 or 4)
    • On renal dialysis
    • Immunosuppressive therapy (systemic corticosteroids, azathioprine, methotrexate, cyclophosphamide,
    • etc.) or an immunodeficiency syndrome
    • Narcotic or alcohol dependence
    • Obstructive sleep apnea (OSA) , defined either by previous diagnosis (with or without use of nasal CPAP), or by a score of 0.80 or higher on the MAP (Multivariate Apnea Prediction), a validated screening algorithm with high positive and negative predictive value for identifying OSA.
  8. Shift-workers.
Both
30 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01038921
IRB00014784, R21 AT 004220-01A2
Yes
Michael Kutner, Emory University
Emory University
Not Provided
Principal Investigator: Michael H Kutner, PhD Emory University
Study Director: Abinav Goyal, M.D. Emory University
Emory University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP