Melatonin and the Metabolic Syndrome (MetSyn)

February 11, 2015 updated by: Michael Kutner, Emory University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
      • Atlanta, Georgia, United States, 30322
        • Emory Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Metabolic Syndrome Components
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Michael H Kutner, PhD, Emory University
  • Study Director: Abinav Goyal, M.D., Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

December 22, 2009

First Submitted That Met QC Criteria

December 23, 2009

First Posted (ESTIMATE)

December 24, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 27, 2015

Last Update Submitted That Met QC Criteria

February 11, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00014784
  • R21AT004220-01A2 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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