Cystic Fibrosis and Endothelial Function: At Rest and During Exercise

• Status: Completed
• Trial end date: 2016-06-21
• Target enrollment: 0
• Participant gender: All

Summary

Perhaps one of the most disturbing aspects of Cystic Fibrosis (CF) is the associated premature death. Oxidative stress has been observed in patients with CF and exercise intolerance has been shown to predict mortality in patients with CF, regardless of how healthy their lungs are. A critical barrier to improving the quality of life and longevity in patients with CF is our lack of knowledge regarding the different reasons why patients with CF cannot exercise to the level of their peers. We have collected preliminary data to support our central hypothesis that oxidative stress contributes to the impairment in blood vessel function at rest and during exercise which ultimately oxygen transport and delivery resulting in exercise intolerance. Exercise is therapeutic medicine for patients with CF and this investigation represents a major breakthrough in the approach to begin understanding the physiological mechanisms which contribute to exercise intolerance in these patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Augusta University
• Treatments: alpha-Tocopherol; Antioxidants; Ascorbic Acid; Thioctic Acid; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

Inclusion Criteria:

• Diagnosis of CF and healthy controls

• Men and women (> 18 yrs. old)

• Boys and girls (7 -17 yrs. old)

• FEV1 percent predicted > 30%

• Resting oxygen saturation (room air) >90%

• Patients with or without CFRD

• Traditional CF-treatment medications

• Ability to perform reliable/reproducible PFTs

• Clinically stable for 2 weeks (no exacerbations or need for antibiotic treatment within 2 weeks of testing or major change in medical status)

Exclusion Criteria:

• Children 6 yrs. old and younger

• FEV1 percent predicted < 30%

• Resting oxygen saturation (room air) < 90%

• Clinical diagnosis of heart disease

• Pulmonary artery hypertension

• Febrile illness within two weeks of visit

• Current smokers

• Currently pregnant or nursing

• Individuals on vaso-active medications (i.e. nitrates, beta blockers, ACE inhibitors, etc.)

• Inability to swallow pills

• Patients with B. Cepacia (only ~3% of our CF center patient population)