Effects and Mechanisms of Melatonin on Blood Pressure, Insulin Resistance, and Platelets
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Thomas Jefferson University
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- Office Systolic Blood pressure change
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Office Systolic Blood pressure change
Time Frame: Baseline to 6 weeks
Change in Systolic blood pressure measured in the office at 6 weeks
Ambulatory Diastolic Blood pressure change
Time Frame: Baseline to 6 weeks
Change in 24 hour average Diastolic blood pressure at 6 weeks
QUICKI: Quantitative insulin sensitivity check index change
Time Frame: Baseline to 6 weeks
Insulin sensitivity measure change at 6 weeks
Office Diastolic Blood pressure change
Time Frame: Baseline to 6 weeks
Change in Diastolic blood pressure measured in the office at 6 weeks
Ambulatory Systolic Blood pressure change
Time Frame: Baseline to 6 weeks
Change in 24 hour average Systolic blood pressure at 6 weeks
HOMA: Homeostasis Model Assessment change
Time Frame: Baseline to 6 weeks
Insulin sensitivity measure change at 6 weeks
Secondary Outcomes
- Arachidonic acid stimulated aggregation change(Baseline to 6 weeks)