Melatonin and the Metabolic Syndrome (MetSyn)
This study is currently recruiting participants.
Verified September 2012 by Emory University
Information provided by (Responsible Party):
Michael Kutner, Emory University
First received: December 22, 2009
Last updated: September 6, 2012
Last verified: September 2012
Melatonin is a hormone that regulates some body functions, including the sleep/wake cycle. Some people take melatonin supplements (over the counter) for promoting sleep. Some studies suggest that melatonin may help improve blood pressure, glucose levels, blood lipid levels, which are components of "the metabolic syndrome." This trial seeks to compare the effects of melatonin supplementation versus placebo on these factors in patients with metabolic syndrome.
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||Melatonin Supplementation and the Metabolic Syndrome: A Phase II Crossover Design Clinical Trial
Primary Outcome Measures:
- Metabolic syndrome components [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||June 2012 (Final data collection date for primary outcome measure)
Melatonin 8mg one hour before bedtime for 10 weeks
Placebo Comparator: Placebo
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.
|Ages Eligible for Study:
||30 Years to 79 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Age 30-79 years.
- Diagnosed with metabolic syndrome according to ATP-III criteria.
- Availability for six months after enrolling in the study.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038921
|Atlanta, Georgia, United States, 30322 |
|Contact: Michael Kutner, MPH 404-712-9708 email@example.com |
||Michael H Kutner, PhD
No publications provided
||Michael Kutner, Professor, Emory University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 22, 2009
||September 6, 2012
||United States: Food and Drug Administration
Keywords provided by Emory University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 17, 2013
Metabolic Syndrome X
Glucose Metabolism Disorders
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action