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Melatonin and the Metabolic Syndrome (MetSyn)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01038921
First Posted: December 24, 2009
Last Update Posted: February 27, 2015
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.
Information provided by (Responsible Party):
Michael Kutner, Emory University
  Purpose
This trial seeks to compare the effects of melatonin supplementation versus placebo in subjects with the metabolic syndrome.

Condition Intervention Phase
Metabolic Syndrome Drug: Melatonin Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Melatonin Supplementation and the Metabolic Syndrome: A Phase II Crossover Design Clinical Trial

Resource links provided by NLM:


Further study details as provided by Michael Kutner, Emory University:

Primary Outcome Measures:
  • Metabolic Syndrome Components [ Time Frame: 3 years ]

Enrollment: 39
Study Start Date: July 2009
Study Completion Date: July 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Melatonin
Melatonin 8mg one hour before bedtime for 10 weeks
Drug: Melatonin
8 mg dose of Melatonin
Placebo Comparator: Placebo
Placebo administered 1 hour before bedtime for 10 weeks
Drug: Placebo
Placebo

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01038921


Locations
United States, Georgia
Emory Hospital
Atlanta, Georgia, United States, 30322
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Michael H Kutner, PhD Emory University
Study Director: Abinav Goyal, M.D. Emory University
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Kutner, Professor, Emory University
ClinicalTrials.gov 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
Last Verified: February 2015

Keywords provided by Michael Kutner, Emory University:
Blood Pressure
Glucose levels
HDL levels
Triglyceride levels
Waist Circumference

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants