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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier:
NCT01059994
First received: January 28, 2010
Last updated: November 18, 2015
Last verified: November 2015
  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: Placebo sildenafil
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 Medical Branch, Galveston:

Primary Outcome Measures:
  • Muscle Fatigue [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    successful isokinetic knee extension repetitions, % baseline day repetitions


Secondary Outcome Measures:
  • Protein Synthesis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Skeletal muscle protein synthesis, measured as the fractional synthesis rate (the percent of the total synthesized per unit time)


Enrollment: 12
Study Start Date: January 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo sildenafil young Drug: Placebo sildenafil
Oral, daily, 1 week.
Other Name: Viagra
Experimental: sildenafil young Drug: Sildenafil
oral, 25mg, daily for 1 week
Other Name: Viagra
Placebo Comparator: placebo sildenafil older Drug: Placebo sildenafil
Oral, daily, 1 week.
Other Name: Viagra
Experimental: sildenafil older Drug: Sildenafil
oral, 25mg, daily for 1 week
Other Name: Viagra

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1. Age 20-35 yrs, and 60-80 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059994

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

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT01059994     History of Changes
Other Study ID Numbers: 09-213 
Study First Received: January 28, 2010
Results First Received: September 25, 2015
Last Updated: November 18, 2015
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 28, 2016