Status:
TERMINATED
Effect of Nitrite on Exercise Physiology and Metabolism
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Healthy
Healthy Volunteer
Eligibility:
All Genders
21-45 years
Phase:
PHASE1
Brief Summary
This study will examine how nitrite infusions affect exercise tolerance (how much a person can exercise before having to stop). Exercise ability is limited by how fast oxygen can be delivered to the b...
Detailed Description
During exercise, there is a lag in the rate at which oxygen uptake (VO2) rises to meet energy demand. It is uncertain whether this limitation is due to inadequate O2 delivery to working muscle, limita...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subjects must be 21-45 years of age.
- Subject must be in good health and able to perform cycle ergometry for the length of the study.
- Subjects must provide informed, written consent for participation in this study.
- Female subjects of childbearing age must have a negative pregnancy test.
- EXCLUSION CRITERIA:
- Subjects with a history of cardiac, pulmonary, peripheral vascular, or mitochondrial disease.
- Subjects with abnormal EKG other than sinus bradycardia.
- Individuals with a future cardiovascular risk greater than 1 % in the next 10 years will be excluded from the study. Risk will be calculated using the Framingham risk calculator published on the web site: http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof.
- Subjects with any physical condition (for example, knee problems) that may impair their performance during exercise testing.
- Subjects who have a history of smoking within one year.
- Subjects with anemia (defined as hemoglobin less than 10 g/dL).
- Subjects with a history of reaction to a medication or other substance characterized by dyspnea and cyanosis will not participate in this study.
- Subjects with G6PD deficiency.
- Subjects with a baseline methemoglobin level greater than 1%.
- Lactating females who are breastfeeding, will not participate since nitrite crosses into breast milk and could cause methemoglobinemia in the infant.
- No volunteer subject will be allowed to take any medication (oral contraceptive agents are allowed), vitamin supplements, herbal preparations, nutriceuticals or other alternative therapies for at least one month prior to study and will not be allowed to take aspirin or NSAIDs for one week prior to study.
- Subjects with a blood pressure of less than 100/70 mmHg on the study day will be excluded from the protocol.
Exclusion
Key Trial Info
Start Date :
March 8 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00105222
Start Date
March 8 2005
End Date
August 16 2013
Last Update
July 5 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892