Phase 2
N=39
Melatonin and the Metabolic Syndrome
Metabolic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01038921 ↗Enrolled (actual)
39
Serious AEs
2.6%
Results posted
May 2014
Primary outcome: Primary: Metabolic Syndrome Components — -2.7; 4.7 mmHg — p=0.013
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Melatonin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Metabolic Syndrome Components |
-2.7; 4.7 | 0.013 sig |
Summary
This trial seeks to compare the effects of melatonin supplementation versus placebo in subjects with the metabolic syndrome.
Eligibility Criteria
Inclusion Criteria
- Age 30-79 years.
- Diagnosed with metabolic syndrome according to AdenosineTriphosphate-III criteria.
- Availability for six months after enrolling in the study.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01038921). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.