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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Prehypertension
• Intervention / Treatment: Dietary supplement: melatonin

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Cynthia Cheng, MD,PhD, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2015
• Primary Completion (Actual): August 9, 2016
• Study Completion (Actual): August 9, 2016

Study Registration Dates

• First Submitted: May 26, 2017
• First Submitted That Met QC Criteria: June 5, 2017
• First Posted (Actual): June 6, 2017

Study Record Updates

• Last Update Posted (Actual): June 8, 2017
• Last Update Submitted That Met QC Criteria: June 6, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Prehypertension; Insulin Resistance; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: 15F.572; R01HL096593 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Summarized data, available immediately by contacting PI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No