Effects and Mechanisms of Melatonin on Blood Pressure, Insulin Resistance, and Platelets

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects and Mechanisms of Melatonin on Blood Pressure, Insulin Resistance, and Platelets

Conditions
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Healthy, Prehypertension

Intervention / Treatment
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* Dietary Supplement: melatonin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normotensive (SBP <120) or prehypertensive (SBP = 120-139 mm Hg) Age: Young/middle-aged (ages 18-45) and (2) 10 elderly subjects ages 65 and older Exclusion Criteria: Patients with a diagnosis of clinical hypertension and/or diabetes mellitus pregnancy coronary or cerebrovascular disease collagen vascular disease, organ failure (heart, kidney, liver). Patients taking anti-inflammatory medications: NSAIDs, corticosteroids, thiazolidinediones, and statins, Patients who have taken melatonin previously in the past year.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Young, intervention<br>patients ages 18-45, taking melatonin | Dietary Supplement: melatonin<br>* controlled release, 9 mg taken 30 minutes before bedtime x 6 weeks<br>* Other names: Life Extension Foundation;|
| No Intervention: Young, control<br>patients ages 18-45, usual care | |
| Experimental: Older, intervention<br>patients ages 60 and older, taking melatonin | Dietary Supplement: melatonin<br>* controlled release, 9 mg taken 30 minutes before bedtime x 6 weeks<br>* Other names: Life Extension Foundation;|
| No Intervention: Older, control<br>patients ages 60 and older, usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arachidonic acid stimulated aggregation change | Platelet activity measure change at 6 weeks | Baseline to 6 weeks |