Clinical trial NCT01038921: Melatonin and the Metabolic Syndrome
Official title: Melatonin Supplementation and the Metabolic Syndrome: A Phase II Crossover Design Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metabolic Syndrome
Keywords: Blood Pressure
Glucose levels
HDL levels
Triglyceride levels
Waist Circumference
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2009-12-24
Enrollment: 39
Sex: ALL
Minimum age (years): 30
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Metabolic Syndrome Components
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Michael H Kutner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Abinav Goyal, M.D.
role: STUDY_DIRECTOR
References:
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.