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

NCT03178396 | Completed DMC

• 2 other identifiers: 15F.572R01HL096593
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Prehypertension; Healthy

Outcome Measures

Primary Outcomes (6)

• Office Systolic Blood pressure change

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

  Baseline to 6 weeks

• Office Diastolic Blood pressure change

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

  Baseline to 6 weeks

• Ambulatory Systolic Blood pressure change

  Change in 24 hour average Systolic blood pressure at 6 weeks

  Baseline to 6 weeks

• Ambulatory Diastolic Blood pressure change

  Change in 24 hour average Diastolic blood pressure at 6 weeks

  Baseline to 6 weeks

• HOMA: Homeostasis Model Assessment change

  Insulin sensitivity measure change at 6 weeks

  Baseline to 6 weeks

• QUICKI: Quantitative insulin sensitivity check index change

  Insulin sensitivity measure change at 6 weeks

  Baseline to 6 weeks

Secondary Outcomes (1)

• Arachidonic acid stimulated aggregation change

  Baseline to 6 weeks

Study Arms (4)

Young, intervention

EXPERIMENTAL

patients ages 18-45, taking melatonin

Dietary Supplement: melatonin

Young, control

NO INTERVENTION

patients ages 18-45, usual care

Older, intervention

EXPERIMENTAL

patients ages 60 and older, taking melatonin

Dietary Supplement: melatonin

Older, control

NO INTERVENTION

patients ages 60 and older, usual care

Interventions

melatonin DIETARY_SUPPLEMENT

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

Also known as: Life Extension Foundation

Older, intervention; Young, intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Prehypertension

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Cynthia Cheng, MD,PhD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: June 6, 2017
• Study Start: December 7, 2015
• Primary Completion: August 9, 2016
• Study Completion: August 9, 2016
• Last Updated: June 8, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)