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, Galveston
ClinicalTrials.gov Identifier:
NCT01059994
First received: January 28, 2010
Last updated: June 5, 2014
Last verified: June 2014

January 28, 2010
June 5, 2014
January 2010
July 2013   (final data collection date for primary outcome measure)
fatigue [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01059994 on ClinicalTrials.gov Archive Site
  • protein synthesis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • nitric oxide synthesis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
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Role of Skeletal Muscle Nitric Oxide Production in Age-related Fatigue and Fatigability
Role of Skeletal Muscle Nitric Oxide Production in Age-related Fatigue and Fatigability

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Fatigue
  • Aging
  • Drug: Sildenafil placebo
    Oral, daily, 1 week.
    Other Name: Viagra
  • Drug: Sildenafil
    oral, 25mg, daily for 1 week
    Other Name: Viagra
  • Placebo Comparator: young placebo
    Intervention: Drug: Sildenafil placebo
  • Placebo Comparator: old placebo
    Intervention: Drug: Sildenafil placebo
  • Experimental: young viagra
    Intervention: Drug: Sildenafil
  • Experimental: old viagra
    Intervention: Drug: Sildenafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2013
July 2013   (final data collection date for primary outcome measure)

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.
Male
20 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01059994
09-213
No
The University of Texas, Galveston
The University of Texas, Galveston
Not Provided
Principal Investigator: William Durham, Ph.D. University of Texas
The University of Texas, Galveston
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP