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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03178396
• Other study ID #: 15F.572
• Secondary ID: R01HL096593
• Status: Completed
• Phase: N/A
• First received: May 26, 2017
• Last updated: June 6, 2017
• Start date: December 7, 2015
• Est. completion date: August 9, 2016

Study information

• Verified date: June 2017
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 9, 2016
• Est. primary completion date: August 9, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Insulin Resistance
• Prehypertension

Intervention

Dietary Supplement:
• melatonin
controlled release, 9 mg taken 30 minutes before bedtime x 6 weeks

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Office Systolic Blood pressure change	Change in Systolic blood pressure measured in the office at 6 weeks	Baseline to 6 weeks
Primary	Office Diastolic Blood pressure change	Change in Diastolic blood pressure measured in the office at 6 weeks	Baseline to 6 weeks
Primary	Ambulatory Systolic Blood pressure change	Change in 24 hour average Systolic blood pressure at 6 weeks	Baseline to 6 weeks
Primary	Ambulatory Diastolic Blood pressure change	Change in 24 hour average Diastolic blood pressure at 6 weeks	Baseline to 6 weeks
Primary	HOMA: Homeostasis Model Assessment change	Insulin sensitivity measure change at 6 weeks	Baseline to 6 weeks
Primary	QUICKI: Quantitative insulin sensitivity check index change	Insulin sensitivity measure change at 6 weeks	Baseline to 6 weeks
Secondary	Arachidonic acid stimulated aggregation change	Platelet activity measure change at 6 weeks	Baseline to 6 weeks