Melatonin and the Metabolic Syndrome
Completed · Phase 2 · Has a placebo group
Conditions studied: Metabolic Syndrome
In brief
This trial seeks to compare the effects of melatonin supplementation versus placebo in subjects with the metabolic syndrome.
Key facts
- Study ID
- NCT01038921
- Run by
- Emory University
- People needed
- 39
- Starts
- 2009-07-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2015-02-27
Who can join
Age: 30 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 30-79 years.
- Diagnosed with metabolic syndrome according to AdenosineTriphosphate-III criteria.
- Availability for six months after enrolling in the study.
You may not qualify if…
- 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.
Where it is running
- Emory Hospital — Atlanta, Georgia, United States
- Emory University — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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