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:
The University of Texas, Galveston
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
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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 June 18, 2013