Status:
COMPLETED
Nitrites, Skeletal Muscle Mitochondrial Bioenergetics, and Physical Activity in Old Age
Lead Sponsor:
Gladwin, Mark, MD
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Conditions:
Aging
Sedentary Lifestyle
Eligibility:
All Genders
70+ years
Phase:
PHASE2
Brief Summary
This 2-site randomized double blinded controlled trial is to confirm and more definitively clarify the impact of a 12-week course of nitrite versus placebo on mitochondrial bioenergetics in older sede...
Detailed Description
Old age is associated with declining skeletal muscle mitochondrial bioenergetics with related decrements in cardiorespiratory fitness (CRF) and physical function that predispose to frailty, disability...
Eligibility Criteria
Inclusion
- Age ≥70 years
- Sedentary (\<1 hour/week of volitional exercise activity)
- Clinically stable (euvolemic; baseline HR \<100 bpm) and without hospitalization or invasive cardiac procedure for 6 weeks
Exclusion
- Blood pressure \<110 or \>160/95 mmHg
- Orthopedic or other chronic condition which limits physical activity or exercise testing assessments
- If valve replacement has been performed, patient may not be enrolled for 12 months after this procedure
- Severe peripheral or pulmonary artery disease
- Anemia: Hgb \<11.0 (♂),10.0 (♀) gm/dl
- Participants with diabetes whose HgbA1c \>10.0%
- Chronic alcohol (\>14 drinks ETOH a week) or drug (any cocaine, methamphetamine, and cannabis ≥4 x week) dependency
- Allergy to lidocaine and red dye
- Chronic use of oral corticosteroids or other medications that affect muscle function
- Current use of organic nitrates or phosphodiesterase type 5 (PDE5) inhibitors
- Unable to hold warfarin, direct-acting oral anticoagulants (DOACs), non-steroidal anti-inflammatory medications (NSAIDs) or aspirin for 3 days prior to muscle biopsy, or to hold thienopyridine medications for 5 days prior to muscle biopsy. Participants unable or unwilling to hold will follow the modified ASA hold plan
- Any bleeding disorder that would contraindicate biopsy such as history of clinically significant bleeding diathesis (e.g., Hemophilia A or B, Von Willebrand's Disease or congenital Factor VII deficiency)
- Unstable psychiatric diagnosis that would affect adherence and ability to complete the protocol
- Dementia or inability to give informed consent or follow study protocol
- End-stage disease
- Other chronic unstable disease such as active neoplasm, end stage chronic kidney, liver or other organ disease
Key Trial Info
Start Date :
April 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2023
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04405180
Start Date
April 23 2021
End Date
July 14 2023
Last Update
October 10 2024
Active Locations (1)
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1
University Of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213