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

Thomas Jefferson University

Status: Completed

Conditions: Healthy; Prehypertension

Treatments: Dietary Supplement: melatonin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03178396

R01HL096593 (U.S. NIH Grant/Contract)

15F.572

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 4 patient groups

Young, intervention

Experimental group

Description:

patients ages 18-45, taking melatonin

Treatment:

Dietary Supplement: melatonin

Young, control

No Intervention group

Description:

patients ages 18-45, usual care

Older, intervention

Experimental group

Description:

patients ages 60 and older, taking melatonin

Treatment:

Dietary Supplement: melatonin

Older, control

No Intervention group

Description:

patients ages 60 and older, usual care