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Completed

NCT Number: NCT03178396

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.

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Key information

Conditions

Prehypertension Cardiovascular Diseases Healthy Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

melatonin

Dietary Supplement

controlled release, 9 mg taken 30 minutes before bedtime x 6 weeks

Other names: Life Extension Foundation

Primary outcomes

  1. Office Systolic Blood pressure change

    Time frame: Baseline to 6 weeks

    Change in Systolic blood pressure measured in the office at 6 weeks

  2. Office Diastolic Blood pressure change

    Time frame: Baseline to 6 weeks

    Change in Diastolic blood pressure measured in the office at 6 weeks

  3. Ambulatory Systolic Blood pressure change

    Time frame: Baseline to 6 weeks

    Change in 24 hour average Systolic blood pressure at 6 weeks

  4. Ambulatory Diastolic Blood pressure change

    Time frame: Baseline to 6 weeks

    Change in 24 hour average Diastolic blood pressure at 6 weeks

  5. HOMA: Homeostasis Model Assessment change

    Time frame: Baseline to 6 weeks

    Insulin sensitivity measure change at 6 weeks

  6. QUICKI: Quantitative insulin sensitivity check index change

    Time frame: Baseline to 6 weeks

    Insulin sensitivity measure change at 6 weeks

Secondary outcomes

  1. Arachidonic acid stimulated aggregation change

    Time frame: Baseline to 6 weeks

    Platelet activity measure change at 6 weeks

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 6, 2017
Registry last updated
Jun 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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