Resveratrol and Vascular Function in CKD

  • STATUS
    Recruiting
  • days left to enroll
    5
  • participants needed
    25
  • sponsor
    Diana Jalal
Updated on 23 March 2022
diabetes
type 2 diabetes mellitus
ace inhibitor
angiotensin
nephropathy
angiotensin converting enzyme

Summary

The proposed research is clinical study evaluating the therapeutic benefits of resveratrol on vascular function in patients with chronic kidney disease (CKD). The study aims to establish that resveratrol will improve endothelial function and functional performance by reducing oxidative stress and in conjunction with lowering markers of inflammation and oxidative stress.

Description

Patients with chronic kidney disease (CKD) have an exceptionally high risk for cardiovascular disease (CVD), and are 10 times more likely to die from CVD prior to requiring dialysis or kidney transplantation. Inflammation, oxidative stress and vascular dysfunction (impaired endothelial function and increased large elastic artery stiffness), are highly prevalent in CKD and contribute to the high incidence of CVD in this patient population. In addition, patients with CKD suffer from high rates of cognitive decline for which we lack effective therapies. Thus, therapeutic interventions targeting inflammation, oxidative stress, vascular dysfunction in CKD are a priority.

Wine intake, which is known to be rich in various polyphenolic compounds, might have a variety of health benefits. Among these polyphenols, the stilbene derivative resveratrol (RSV), a naturally occurring polyphenol found in grapes and red wine, has recently come to light, as it has been shown to exert potent anti-diabetic, anti-oxidative and anti-inflammatory actions. Importantly, recent studies have demonstrated that resveratrol is well-tolerated (37) and may confer similar benefits in individuals at high risk of CVD, such as improved endothelial function in individuals with metabolic syndrome (i.e. diabetes)

The primary goal of this application is to determine whether 6 wks resveratrol (RSV) supplementation improves vascular function by reducing oxidative stress in a randomized, double-blind, cross-over study of 25 patients with diabetic kidney disease. The investigators hypothesize that: 1) 6 wks RSV will improve vascular function as measured via BA-FMD vs. placebo and 2) that the improvement in vascular function will be related, at least partially, to a reduction in oxidative stress.

Details
Condition Chronic Kidney Diseases, Endothelial Dysfunction
Treatment Placebo, Resveratrol
Clinical Study IdentifierNCT03597568
SponsorDiana Jalal
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

CKD stage III (estimated GFR: 30-60 mL/MIN/1.73m2)
Able to give informed consent
Angiotensin converting enzyme inhibitor or angiotensin II receptor bloocker for > 3 month prior to the study
Type II diabetes mellitus

Exclusion Criteria

Consuming > 2 glasses/day red wine and/or taking resveratrol or vitamin C supplement in the past 12 months
Life expectancy <1 year
BMI >40 kg/m2 1
Pregnant, breastfeeding, or unwilling to use adequate birth control
Uncontrolled hypertension; blood pressure > 140/90
Uncontrolled type II DM; AIC > 8.5
Currently taking anticoagulants including: coumadin, dalteparin, enoxaparin, haparin, and plavix
Severe liver disease
Severe systolic heart failure
Hospitalization within the last 3 months
Active infection or antibiotic therapy
Immunosuppressive therapy within the last year
Currently partaking in another research study
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note