Aging Clinical Trial
Official title:
Role of Skeletal Muscle Nitric Oxide Production in Age-related Fatigue and Fatigability
NCT number | NCT01059994 |
Other study ID # | 09-213 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2010 |
Est. completion date | July 2013 |
Verified date | November 2018 |
Source | The University of Texas Medical Branch, Galveston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Medical Branch | Galveston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Medical Branch, Galveston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Muscle Fatigue After 1 Week of Placebo or Sildenafil | Muscle fatigue was tested before and after 1 week of placebo/sildenafil (25mg/day) treatment. Subjects were asked to perform maximum effort isokinetic knee extensions until force production reached 50% of their MVC (maximum voluntary contraction). Data was collected as number of successful repetitions completed between start and 50% MVC. Data is presented as percent change in repetitions (1 week of treatment / baseline). |
baseline to 1 week | |
Secondary | Protein Synthesis Rate After 1 Week of Sildenafil or Placebo | Skeletal muscle protein synthesis, measured as the fractional synthesis rate (the percent of the total synthesized per unit time) after 1 week of either Placebo or Sildenafil (25 mg/day). Example: if FSR = 0.06 hr-1 it means that 6% of proteins in a given sample were synthesized in the last hour or proteins is synthesized at 6% per hour. A higher rate means that more synthesis is occurring. | 1 week |
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