Melatonin and the Metabolic Syndrome (MetSyn)

Emory University

Status and phase: Completed; Phase 2

Conditions: Metabolic Syndrome

Treatments: Drug: Placebo; Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT01038921

R21AT004220-01A2 (U.S. NIH Grant/Contract)

IRB00014784

Details and patient eligibility

About

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

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 30 to 79 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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39 participants in 2 patient groups, including a placebo group

Melatonin

Experimental group

Description:

Melatonin 8mg one hour before bedtime for 10 weeks

Treatment:

Drug: Melatonin

Placebo

Placebo Comparator group

Description:

Placebo administered 1 hour before bedtime for 10 weeks

Treatment:

Drug: Placebo