Metabolic Syndrome
Conditions
Keywords
Blood Pressure, Glucose levels, HDL levels, Triglyceride levels, Waist Circumference
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.
Interventions
DRUGMelatonin
8 mg dose of Melatonin
DRUGPlacebo
Placebo
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metabolic Syndrome Components | 3 years |
Countries
United States
Participant flow
Recruitment details
Recruitment period from 05/24/2010 through 12/15/2011. Recruitment was from subjects from the Screening for Impaired Glucose Tolerance: Glucose Challenge versus Predictive Model NIH study R18DK066204,from Preventive Cardiology Clinic at Emory University Clinic and from advertisements placed on the campus of the Emory Clinic
Pre-assignment details
One week run in period on placebo. Six week washout period between crossover.
Participants by arm
| Arm | Count |
|---|---|
| Melatonin First Cross-over design with subjects receiving Melatonin First | 19 |
| Placebo First Cross-over design with subjects receiving Placebo First | 20 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo First | Total | Melatonin First |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 6 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 33 Participants | 15 Participants |
| Age, Continuous | 57.6 years STANDARD_DEVIATION 10.1 | 58.9 years STANDARD_DEVIATION 10.4 | 62.7 years STANDARD_DEVIATION 9.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 13 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 24 Participants | 13 Participants |
| Region of Enrollment United States | 20 participants | 39 participants | 19 participants |
| Sex: Female, Male Female | 8 Participants | 17 Participants | 9 Participants |
| Sex: Female, Male Male | 12 Participants | 22 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 20 |
| serious Total, serious adverse events | 0 / 19 | 1 / 20 |
Outcome results
Primary
Metabolic Syndrome Components
Time frame: 3 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Melatonin | Metabolic Syndrome Components | -2.7 mmHg | Standard Deviation 11.3 |
| Placebo | Metabolic Syndrome Components | 4.7 mmHg | Standard Deviation 13.8 |
Comparison: Average change in systolic blood pressure from pre-treatment baseline to post-treatment at 10 weeks when those subjects were on Melatonin was compared to the average change in systolic blood pressure from pre-treatment baseline to post-treatment at 10 weeks when those same subjects were on Placebo using an intent-to-treat mixed model. Power was estimated based on having 30 subjects completing both the melatonin arm and the placebo arm.p-value: 0.013Mixed Models Analysis