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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 28, 2010

Last Updated Date

February 11, 2013

Start Date ^ICMJE

January 2010

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

fatigue [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01059994 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Fatigue
Aging

Intervention ^ICMJE

Drug: Sildenafil placebo
Oral, daily, 1 week.

Other Name: Viagra
Drug: Sildenafil
oral, 25mg, daily for 1 week

Other Name: Viagra

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

20 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Kathleen Randolph

409-772-8126

kmrandol@utmb.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01059994

Other Study ID Numbers ^ICMJE

09-213

Has Data Monitoring Committee

Responsible Party

The University of Texas, Galveston

Study Sponsor ^ICMJE

The University of Texas, Galveston

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

William Durham, Ph.D.

University of Texas

Information Provided By

The University of Texas, Galveston

Verification Date

February 2013

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

To Top