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Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resveratrol
Placebo
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Resveratrol

Placebo

Arm Description

500 mg of time released micronized trans-Resveratrol

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

Outcomes

Primary Outcome Measures

Change in Sirt1 concentrations
Circulating concentrations of Sirt1 before and 12 weeks after both resveratrol and placebo
Change in vascular health
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.
Change in Systemic Inflammation
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

Change in Nitric Oxide metabolism
Nitric oxide metabolism will be evaluated through Nitric oxide synthase expression using western blot analysis
Change in Inflammatory activation
The inflammatory cascade of the nuclear factor kappa B will be evaluated through assessment of p65 and p50 expression using western blot analysis

Full Information

First Posted
December 12, 2018
Last Updated
September 22, 2023
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT03819517
Brief Title
Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease
Official Title
Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease: a Mechanistic Approach
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resveratrol
Arm Type
Active Comparator
Arm Description
500 mg of time released micronized trans-Resveratrol
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be used in the form of an empty white colored soft vegetarian capsule as resveratrol is presented
Intervention Type
Dietary Supplement
Intervention Name(s)
Resveratrol
Intervention Description
Over the counter supplementation
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Empty white colored soft vegetarian capsule
Primary Outcome Measure Information:
Title
Change in Sirt1 concentrations
Description
Circulating concentrations of Sirt1 before and 12 weeks after both resveratrol and placebo
Time Frame
Baseline to 12 weeks
Title
Change in vascular health
Description
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.
Time Frame
Baseline to 12 weeks
Title
Change in Systemic Inflammation
Description
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.
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change in Nitric Oxide metabolism
Description
Nitric oxide metabolism will be evaluated through Nitric oxide synthase expression using western blot analysis
Time Frame
Baseline to 12 weeks
Title
Change in Inflammatory activation
Description
The inflammatory cascade of the nuclear factor kappa B will be evaluated through assessment of p65 and p50 expression using western blot analysis
Time Frame
Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Rodriguez Miguelez, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease

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