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| ID | Type | Description | Link |
|---|---|---|---|
| R21AT004220-01A2 | U.S. NIH Grant/Contract | View source |
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This trial seeks to compare the effects of melatonin supplementation versus placebo in subjects with the metabolic syndrome.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin | Experimental | Melatonin 8mg one hour before bedtime for 10 weeks |
|
| Placebo | Placebo Comparator | Placebo administered 1 hour before bedtime for 10 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | 8 mg dose of Melatonin |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic Syndrome Components | 3 years |
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Inclusion Criteria:
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:
Shift-workers.
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| Name | Affiliation | Role |
|---|---|---|
| Michael H Kutner, PhD | Emory University | Principal Investigator |
| Abinav Goyal, M.D. | Emory University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Hospital | Atlanta | Georgia | 30322 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25937837 | Derived | 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. |
| Label | URL |
|---|---|
| Published manuscript describing the study design of Melatonin Supplementation and the Metabolic Syndrone | View source |
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One week run in period on placebo. Six week washout period between crossover.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Melatonin | Cross-over design with subject receiving either Melatonin First and Placebo Second or Placebo First and Melatonin Second |
| FG001 | Placebo | Cross-over design with subjects receiving either Placebo First and Melatonin Second or Melatonin First and Placebo Second |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Expected to enroll 40 subjects but only randomized 39 subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Melatonin First | Cross-over design with subjects receiving Melatonin First |
| BG001 | Placebo First | Cross-over design with subjects receiving Placebo First |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Metabolic Syndrome Components | Posted | Mean | Standard Deviation | mmHg | 3 years |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Melatonin First | Cross-over design for subjects randomized to Melatonin First, Placebo Second |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild stroke | Cardiac disorders | SNOMED CT | Non-systematic Assessment |
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Study was designed as a pilot Phase II cross-over design to study the safety of melatonin and to estimate the effect sizes associated with average changes while subjects were on melatonin versus average changes while subjects were on placebo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Abinav Goyal | Emory University | 404-727-8758 | agoyal4@emory.edu |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
Placebo |
|
| Atlanta |
| Georgia |
| 30322 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Melatonin First Placebo First Caucasian 13 11 African American 6 7 Other 0 2 | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Placebo First | Cross-over design for subjects randomized to Placebo First, Melatonin Second | 1 | 20 | 0 | 20 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |