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

Not Applicable

Completed

• Conditions: Healthy; Prehypertension
• Interventions: Dietary Supplement: melatonin

• Registration Number: NCT03178396
• Lead Sponsor: Thomas Jefferson University

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 Timeline

• Study Start: 2015-12-07
• Primary Completion: 2016-08-09
• Study Completion: 2016-08-09
• Study First Submitted: 2017-05-26
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-05
• Study First Posted: 2017-06-06
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Young, intervention	melatonin	patients ages 18-45, taking melatonin
Older, intervention	melatonin	patients ages 60 and older, taking melatonin

Primary Outcome Measures

Name	Time	Method
Office Systolic Blood pressure change	Baseline to 6 weeks	Change in Systolic blood pressure measured in the office at 6 weeks
Ambulatory Diastolic Blood pressure change	Baseline to 6 weeks	Change in 24 hour average Diastolic blood pressure at 6 weeks
QUICKI: Quantitative insulin sensitivity check index change	Baseline to 6 weeks	Insulin sensitivity measure change at 6 weeks
Office Diastolic Blood pressure change	Baseline to 6 weeks	Change in Diastolic blood pressure measured in the office at 6 weeks
Ambulatory Systolic Blood pressure change	Baseline to 6 weeks	Change in 24 hour average Systolic blood pressure at 6 weeks
HOMA: Homeostasis Model Assessment change	Baseline to 6 weeks	Insulin sensitivity measure change at 6 weeks

Secondary Outcome Measures

Name	Time	Method
Arachidonic acid stimulated aggregation change	Baseline to 6 weeks	Platelet activity measure change at 6 weeks

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States