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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 Emory University:

Primary Outcome Measures:
  • Metabolic Syndrome Components [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   30 Years to 79 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038921

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Emory Hospital
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:
No publications provided

Responsible Party: Michael Kutner, Professor, 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

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

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

ClinicalTrials.gov processed this record on August 25, 2014