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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL096593 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The investigators will be studying the effect of melatonin on blood pressure, insulin resistance, and platelets, along with possible reasons for how melatonin cases these effects.
The investigators will be studying the effect of melatonin on blood pressure and insulin resistance, and possible reasons for how melatonin works on blood pressure and IR. Along with blood testing to measure adipokines, insulin resistance (IR), and platelet function (how well your blood clots), 24-hour ambulatory blood pressure monitoring (ABPM) will be used to measure blood pressure, since ABPM is the gold standard (best method) for accurate assessment of blood pressure status and associated cardiovascular risk. Vascular (blood vessel) function, IR, adipokine levels and sleep quality will also be measured. All study endpoints will be measured at baseline and following 6 weeks of daily melatonin 9 mg dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Young, intervention | Experimental | patients ages 18-45, taking melatonin |
|
| Young, control | No Intervention | patients ages 18-45, usual care | |
| Older, intervention | Experimental | patients ages 60 and older, taking melatonin |
|
| Older, control | No Intervention | patients ages 60 and older, usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| melatonin | Dietary Supplement | controlled release, 9 mg taken 30 minutes before bedtime x 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Office Systolic Blood pressure change | Change in Systolic blood pressure measured in the office at 6 weeks | Baseline to 6 weeks |
| Office Diastolic Blood pressure change | Change in Diastolic blood pressure measured in the office at 6 weeks | Baseline to 6 weeks |
| Ambulatory Systolic Blood pressure change | Change in 24 hour average Systolic blood pressure at 6 weeks | Baseline to 6 weeks |
| Ambulatory Diastolic Blood pressure change | Change in 24 hour average Diastolic blood pressure at 6 weeks | Baseline to 6 weeks |
| HOMA: Homeostasis Model Assessment change | Insulin sensitivity measure change at 6 weeks | Baseline to 6 weeks |
| QUICKI: Quantitative insulin sensitivity check index change | Insulin sensitivity measure change at 6 weeks | Baseline to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Arachidonic acid stimulated aggregation change | Platelet activity measure change at 6 weeks | Baseline to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Patients with a diagnosis of
Patients taking anti-inflammatory medications: NSAIDs, corticosteroids, thiazolidinediones, and statins,
Patients who have taken melatonin previously in the past year.
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Cheng, MD,PhD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
Summarized data, available immediately by contacting PI
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| ID | Term |
|---|---|
| D058246 | Prehypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular 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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| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |