PrehypertensionNCT03178396
Effects and Mechanisms of Melatonin on Blood Pressure, Insulin Resistance, and Platelets
A study testing melatonin in people with Prehypertension and Healthy, run by Thomas Jefferson University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prehypertension, Healthy
- What is being tested?
- melatonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2015to 9 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
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.
Read the 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.
- Conditions
- Prehypertension, Healthy
- Being tested
- melatonin
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatoninDietary supplement
Also called Life Extension Foundation
controlled release, 9 mg taken 30 minutes before bedtime x 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Young, intervention | Experimental | patients ages 18-45, taking melatonin Receives: Dietary Supplement: melatonin |
| Young, control | No intervention | patients ages 18-45, usual care |
| Older, intervention | Experimental | patients ages 60 and older, taking melatonin Receives: Dietary Supplement: melatonin |
| Older, control | No intervention | patients ages 60 and older, usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Office Systolic Blood pressure change
Change in Systolic blood pressure measured in the office at 6 weeks
Measured: Baseline to 6 weeks
Office Diastolic Blood pressure change
Change in Diastolic blood pressure measured in the office at 6 weeks
Measured: Baseline to 6 weeks
Ambulatory Systolic Blood pressure change
Change in 24 hour average Systolic blood pressure at 6 weeks
Measured: Baseline to 6 weeks
Ambulatory Diastolic Blood pressure change
Change in 24 hour average Diastolic blood pressure at 6 weeks
Measured: Baseline to 6 weeks
HOMA: Homeostasis Model Assessment change
Insulin sensitivity measure change at 6 weeks
Measured: Baseline to 6 weeks
QUICKI: Quantitative insulin sensitivity check index change
Insulin sensitivity measure change at 6 weeks
Measured: Baseline to 6 weeks
Secondary outcomes (1)
Arachidonic acid stimulated aggregation change
Platelet activity measure change at 6 weeks
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start7 Dec 2015
- Primary completion9 Aug 2016
- Study completion9 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehypertensionStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Cynthia Cheng, MD,PhD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178396
- Sponsor's protocol ID
- 15F.572
- Other IDs
- R01HL096593
- Status last verified
- Jun 2017
- First submitted
- 26 May 2017
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Summarized data, available immediately by contacting PI
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Mechanisms of Melatonin on Blood Pressure, Insulin Resistance, and Platelets
- ClinicalTrials.gov ID
- NCT03178396
- Acronym / sponsor ID
- 15F.572
- Conditions
- Prehypertension, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 7 Dec 2015 (actual)
- Primary completion
- 9 Aug 2016 (actual)
- Study completion
- 9 Aug 2016 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Young, intervention | Experimental | Dietary Supplement: melatoninpatients ages 18-45, taking melatonin |
| Young, control | No intervention | –patients ages 18-45, usual care |
| Older, intervention | Experimental | Dietary Supplement: melatoninpatients ages 60 and older, taking melatonin |
| Older, control | No intervention | –patients ages 60 and older, usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- Patients with a diagnosis of
- Patients taking anti-inflammatory medications: NSAIDs, corticosteroids, thiazolidinediones, and statins,
- Patients who have taken melatonin previously in the past year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| melatoninAlso: Life Extension Foundationcontrolled release, 9 mg taken 30 minutes before bedtime x 6 weeks | Dietary supplement | Older, intervention, Young, intervention |
Primary outcome
Office Systolic Blood pressure change
Time frame: Baseline to 6 weeks
Change in Systolic blood pressure measured in the office at 6 weeks
Office Diastolic Blood pressure change
Time frame: Baseline to 6 weeks
Change in Diastolic blood pressure measured in the office at 6 weeks
Ambulatory Systolic Blood pressure change
Time frame: Baseline to 6 weeks
Change in 24 hour average Systolic blood pressure at 6 weeks
Ambulatory Diastolic Blood pressure change
Time frame: Baseline to 6 weeks
Change in 24 hour average Diastolic blood pressure at 6 weeks
HOMA: Homeostasis Model Assessment change
Time frame: Baseline to 6 weeks
Insulin sensitivity measure change at 6 weeks
QUICKI: Quantitative insulin sensitivity check index change
Time frame: Baseline to 6 weeks
Insulin sensitivity measure change at 6 weeks
1 secondary outcome
Arachidonic acid stimulated aggregation change
Time frame: Baseline to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Individual participant dataSharing planned: Yes. Summarized data, available immediately by contacting PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Cheng, MD,PhD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing melatonin in people with Prehypertension and Healthy, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Office Systolic Blood pressure change (time frame: Baseline to 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2017.