Melatonin and the Metabolic Syndrome

Phase 2

Completed

• Conditions: Metabolic Syndrome
• Interventions: Drug: Placebo; Drug: Melatonin

• Registration Number: NCT01038921
• Lead Sponsor: Emory University

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-12-22
• Study First Submitted QC: 2009-12-23
• Study First Posted: 2009-12-24
• Primary Completion: 2012-06
• Study Completion: 2013-07
• Results First Submitted: 2013-08-13
• Results First Submitted QC: 2014-04-01
• Results First Posted: 2014-05-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-11
• Last Update Posted: 2015-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo administered 1 hour before bedtime for 10 weeks
Melatonin	Melatonin	Melatonin 8mg one hour before bedtime for 10 weeks

Primary Outcome Measures

Name	Time	Method
Metabolic Syndrome Components	3 years

Trial Locations

Locations (2)

Emory University; 🇺🇸 Atlanta, Georgia, United States

Emory Hospital; 🇺🇸 Atlanta, Georgia, United States