search
Back to results

Melatonin and the Metabolic Syndrome (MetSyn)

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Melatonin
Placebo
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Blood Pressure, Glucose levels, HDL levels, Triglyceride levels, Waist Circumference

Eligibility Criteria

30 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Emory Hospital
  • Emory University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Melatonin

Placebo

Arm Description

Melatonin 8mg one hour before bedtime for 10 weeks

Placebo administered 1 hour before bedtime for 10 weeks

Outcomes

Primary Outcome Measures

Metabolic Syndrome Components

Secondary Outcome Measures

Full Information

First Posted
December 22, 2009
Last Updated
February 11, 2015
Sponsor
Emory University
search

1. Study Identification

Unique Protocol Identification Number
NCT01038921
Brief Title
Melatonin and the Metabolic Syndrome
Acronym
MetSyn
Official Title
Melatonin Supplementation and the Metabolic Syndrome: A Phase II Crossover Design Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Blood Pressure, Glucose levels, HDL levels, Triglyceride levels, Waist Circumference

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melatonin
Arm Type
Experimental
Arm Description
Melatonin 8mg one hour before bedtime for 10 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered 1 hour before bedtime for 10 weeks
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Description
8 mg dose of Melatonin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Metabolic Syndrome Components
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 30-79 years. Diagnosed with metabolic syndrome according to AdenosineTriphosphate-III criteria. Availability for six months after enrolling in the study. Exclusion Criteria: Inability to understand informed consent and to cooperate with study procedures. Supplemental intake of melatonin. Current smoking. Current use of calcium channel blockers. Current, planned, or recent (12 months) participation in another clinical trial. Women who are pregnant, breast-feeding, attempting conception, or planning to attempt conception over the next 6 months. 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. Shift-workers.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael H Kutner, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abinav Goyal, M.D.
Organizational Affiliation
Emory University
Official's Role
Study Director
Facility Information:
Facility Name
Emory Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25937837
Citation
Goyal A, Terry PD, Superak HM, Nell-Dybdahl CL, Chowdhury R, Phillips LS, Kutner MH. Melatonin supplementation to treat the metabolic syndrome: a randomized controlled trial. Diabetol Metab Syndr. 2014 Nov 18;6:124. doi: 10.1186/1758-5996-6-124. eCollection 2014.
Results Reference
derived
Links:
URL
http://www.dovepress.com/design-and-rationale-of-a-randomized-controlled-trial-of-melatonin-sup-peer-reviewed-article-OAJCT-recommendation1
Description
Published manuscript describing the study design of Melatonin Supplementation and the Metabolic Syndrone

Learn more about this trial

Melatonin and the Metabolic Syndrome

We'll reach out to this number within 24 hrs