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Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03819517
Recruitment Status : Active, not recruiting
First Posted : January 28, 2019
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
Researchers have found a link between chronic obstructive pulmonary disease (COPD) and heart disease; however, a link is all they have found. Cardiovascular health in COPD is controlled by different mechanisms including vascular health and systemic inflammation. The investigators have collected preliminary data to support that concentrations of Sirtuin 1 (Sirt1), a protein that plays a key role in cardioprotection, may be involved in cardiovascular health in patients with COPD. Resveratrol, an over the counter natural polyphenol found in a variety of food, is a direct activator of Sirt1 and has been used to improve cardiovascular health in different cohorts. The current project is an attempt to expand previous findings and explore the effects of the sub-chronic use of resveratrol in sustaining the improvements in cardiovascular health in COPD.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Dietary Supplement: Resveratrol Other: Placebo Not Applicable

Detailed Description:
The present study is designed as a double-blind, randomized, cross-over, placebo-controlled protocol. Patients with COPD will receive either resveratrol (500 mg) or placebo for 12 weeks. A comprehensive evaluation of cardiovascular health will be performed. Results will provide novel insights into the mechanistic role that Sirt1 mediates in COPD related vascular dysfunction and systemic inflammation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease: a Mechanistic Approach
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
Drug Information available for: Resveratrol

Arm Intervention/treatment
Active Comparator: Resveratrol
500 mg of time released micronized trans-Resveratrol
Dietary Supplement: Resveratrol
Over the counter supplementation

Placebo Comparator: Placebo
Placebo will be used in the form of an empty white colored soft vegetarian capsule as resveratrol is presented
Other: Placebo
Empty white colored soft vegetarian capsule




Primary Outcome Measures :
  1. Change in Sirt1 concentrations [ Time Frame: Baseline to 12 weeks ]
    Circulating concentrations of Sirt1 before and 12 weeks after both resveratrol and placebo

  2. Change in vascular health [ Time Frame: Baseline to 12 weeks ]
    Assessment of vascular health through the evaluation of peripheral vascular using the flow-mediated dilation technique before and 12 weeks after both resveratrol and placebo.

  3. Change in Systemic Inflammation [ Time Frame: Baseline to 12 weeks ]
    Systemic inflammation will be evaluated through the assessment of interleukin concentrations using enzyme-linked immunosorbent assay before and 12 weeks after both resveratrol and placebo.


Secondary Outcome Measures :
  1. Change in Nitric Oxide metabolism [ Time Frame: Baseline to 12 weeks ]
    Nitric oxide metabolism will be evaluated through Nitric oxide synthase expression using western blot analysis

  2. Change in Inflammatory activation [ Time Frame: Baseline to 12 weeks ]
    The inflammatory cascade of the nuclear factor kappa B will be evaluated through assessment of p65 and p50 expression using western blot analysis



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants with a clinical diagnosis of COPD known for at least one year will be allowed to participate
  • Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages II to IV
  • Breathing test ratio (FEV1/FVC) <0.7
  • Amount of exhaled air (FEV1) <80% predicted after bronchodilator
  • Total Lung Capacity (TLC)>80%
  • Matched healthy volunteers without COPD.

Exclusion Criteria:

  • FEV1/FVC>0.7
  • Clinical diagnosis of heart disease, hypertension or diabetes
  • Use of vasoactive medications (nitrates, Beta blockers)
  • Uncontrolled high blood pressure
  • Pulmonary hypertension
  • Fluid in the lungs
  • Sleep apnea
  • Thyroid problems
  • Anemia
  • Raynaud's phenomenon
  • Gastrointestinal bleeding
  • History of coagulopathies
  • History of low platelets
  • Gangrene of the digits
  • Phenylketonuria
  • Pregnant or women attempting to become pregnant
  • In lactation
  • Individuals who may not be able to read or understand the resveratrol label

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819517


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Paula Rodriguez Miguelez, PhD Virginia Commonwealth University
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03819517    
Other Study ID Numbers: HM20014536
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Virginia Commonwealth University:
COPD
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents