Role of Skeletal Muscle Nitric Oxide Production in Age-related Fatigue and Fatigability

This study is currently recruiting participants.
Verified February 2013 by The University of Texas, Galveston
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT01059994
First received: January 28, 2010
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

This is a pilot study funded by the National Institutes of Health. In this project, we will investigate the potential effect of skeletal muscle nitric oxide (NO) production on muscle strength and physical function in older individuals. We propose to test a new method that may enable simultaneous determination of both vascular and skeletal muscle NO production for the first time in humans. Further, we will determine whether augmentation of NO-mediated responses, by administration of sildenafil citrate (Viagra), reduces fatigue and fatigability in older individuals.


Condition Intervention
Fatigue
Aging
Drug: Sildenafil placebo
Drug: Sildenafil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Role of Skeletal Muscle Nitric Oxide Production in Age-related Fatigue and Fatigability

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • fatigue [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • protein synthesis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • nitric oxide synthesis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2010
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: young placebo Drug: Sildenafil placebo
Oral, daily, 1 week.
Other Name: Viagra
Placebo Comparator: old placebo Drug: Sildenafil placebo
Oral, daily, 1 week.
Other Name: Viagra
Experimental: young viagra Drug: Sildenafil
oral, 25mg, daily for 1 week
Other Name: Viagra
Experimental: old viagra Drug: Sildenafil
oral, 25mg, daily for 1 week
Other Name: Viagra

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1. Age 20-35 yrs, and 60-75 yrs.
  • 2. Ability to sign consent form (score >23 on the 30-item Mini Mental State Examination, MMSE)
  • 3. Stable body weight for at least 3 months

Exclusion Criteria:

  • 1. Physical dependence or frailty (impairment in any of the Activities of Daily Living (ADL), history of falls (>2/year) or significant weight loss in the past year)
  • 2. Exercise training (>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)
  • 3. Pregnancy
  • 4. Significant heart, liver, kidney, blood or respiratory disease
  • 5. Peripheral vascular disease
  • 6. Diabetes mellitus or other untreated endocrine disease
  • 7. Active cancer
  • 8. Use of nitrates
  • 9. Recent (within 6 months) treatment with anabolic steroids, or corticosteroids.
  • 10. Alcohol or drug abuse
  • 11. Severe depression (>5 on the 15-item Geriatric Depression Scale, GDS)
  • 12. Cardiac abnormalities such as a cardiac shunt or previously diagnosed pulmonary hypertension.
  • 13. Systolic blood pressure <100 or >150, diastolic blood pressure <60 or >90.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059994

Contacts
Contact: Kathleen Randolph 409-772-8126 kmrandol@utmb.edu

Locations
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas, Galveston
Investigators
Principal Investigator: William Durham, Ph.D. University of Texas
  More Information

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT01059994     History of Changes
Other Study ID Numbers: 09-213
Study First Received: January 28, 2010
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:
fatigue
aging

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
Nitric Oxide
Sildenafil
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014