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

Primary Purpose

Prehypertension, Healthy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

melatonin

About this trial

This is an interventional prevention trial for Prehypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Thomas Jefferson University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Young, intervention

Young, control

Older, intervention

Older, control

Arm Description

patients ages 18-45, taking melatonin

patients ages 18-45, usual care

patients ages 60 and older, taking melatonin

patients ages 60 and older, usual care

Outcomes

Primary Outcome Measures

Office Systolic Blood pressure change

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

Office Diastolic Blood pressure change

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

Ambulatory Systolic Blood pressure change

Change in 24 hour average Systolic blood pressure at 6 weeks

Ambulatory Diastolic Blood pressure change

Change in 24 hour average Diastolic blood pressure at 6 weeks

HOMA: Homeostasis Model Assessment change

Insulin sensitivity measure change at 6 weeks

QUICKI: Quantitative insulin sensitivity check index change

Insulin sensitivity measure change at 6 weeks

Secondary Outcome Measures

Arachidonic acid stimulated aggregation change

Platelet activity measure change at 6 weeks

Full Information

NCT ID

NCT03178396

First Posted

May 26, 2017

Last Updated

June 6, 2017

Sponsor

Thomas Jefferson University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT03178396

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

December 7, 2015 (Actual)

Primary Completion Date

August 9, 2016 (Actual)

Study Completion Date

August 9, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Thomas Jefferson University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prehypertension, Healthy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Young, intervention

Arm Type

Experimental

Arm Description

patients ages 18-45, taking melatonin

Arm Title

Young, control

Arm Type

No Intervention

Arm Description

patients ages 18-45, usual care

Arm Title

Older, intervention

Arm Type

Experimental

Arm Description

patients ages 60 and older, taking melatonin

Arm Title

Older, control

Arm Type

No Intervention

Arm Description

patients ages 60 and older, usual care

Intervention Type

Dietary Supplement

Intervention Name(s)

melatonin

Other Intervention Name(s)

Life Extension Foundation

Intervention Description

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

Primary Outcome Measure Information:

Title

Office Systolic Blood pressure change

Description

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

Time Frame

Baseline to 6 weeks

Title

Office Diastolic Blood pressure change

Description

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

Time Frame

Baseline to 6 weeks

Title

Ambulatory Systolic Blood pressure change

Description

Change in 24 hour average Systolic blood pressure at 6 weeks

Time Frame

Baseline to 6 weeks

Title

Ambulatory Diastolic Blood pressure change

Description

Change in 24 hour average Diastolic blood pressure at 6 weeks

Time Frame

Baseline to 6 weeks

Title

HOMA: Homeostasis Model Assessment change

Description

Insulin sensitivity measure change at 6 weeks

Time Frame

Baseline to 6 weeks

Title

QUICKI: Quantitative insulin sensitivity check index change

Description

Insulin sensitivity measure change at 6 weeks

Time Frame

Baseline to 6 weeks

Secondary Outcome Measure Information:

Title

Arachidonic acid stimulated aggregation change

Description

Platelet activity measure change at 6 weeks

Time Frame

Baseline to 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cynthia Cheng, MD,PhD

Organizational Affiliation

Thomas Jefferson University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Thomas Jefferson University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Summarized data, available immediately by contacting PI

Learn more about this trial

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

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