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
Sponsored by
About this trial
This is an interventional prevention trial for Prehypertension
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.
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
No
Studies a U.S. FDA-regulated Device Product
No
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
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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