Melatonin and the Metabolic Syndrome

Metabolic Syndrome Clinical Trial

— MetSyn  

Official title:

Melatonin Supplementation and the Metabolic Syndrome: A Phase II Crossover Design Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01038921
• Other study ID #: IRB00014784
• Secondary ID: R21AT004220-01A2
• Status: Completed
• Phase: Phase 2
• First received: December 22, 2009
• Last updated: February 11, 2015
• Start date: July 2009
• Est. completion date: July 2013

Study information

• Verified date: February 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• Melatonin
8 mg dose of Melatonin
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Emory Hospital	Atlanta	Georgia
United States	Emory University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic Syndrome Components		3 years	No

External Links

•   Published manuscript describing the study design of Melatonin Supplementation and the Metabolic Syndrone