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Clinical Trials/NCT05458232
NCT05458232WithdrawnNot Applicable

Use of a Phosphodiesterase Type 5 Inhibitor to Improve Anabolic Resistance in Older Adults

University of Arkansas1 site in 1 countryStarted: January 20, 2023Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
Change in maximal voluntary contraction of lower leg.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study will be the first demonstration of the utility and feasibility of Phosphodiesterase Type 5 inhibitor as an effective pharmacological therapy for improving anabolic resistant states.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
60 Years to 75 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Ages 60-75 yrs
  • •Recently prescribed 5mg of tadalafil daily for clinical purposes

Exclusion Criteria

  • •History of diabetes
  • •history of hypotension including orthostatic hypotension
  • •History of malignancy or chemo/radiation therapy in the 6 months prior to enrollment
  • •History of short gut syndrome, gastrointestinal bypass/reduction surgery (Lap band, gastric sleeve, etc.)
  • •Subjects who cannot refrain from using protein or amino acid supplements for 7 days prior to Visit 2 and
  • •Alcohol consumption of ≥ 5 units/servings per day
  • •Concomitant use of
  • •oral or injectable corticosteroids
  • •testosterone, insulin like growth factor-1, or similar anabolic agent
  • •riociguat (Adempas)
  • •nitroglycerin
  • •isosorbide dinitrate (Isordil)
  • •isosorbide mononitrate (Imdur, Monoket)
  • •doxazosin (Cardura)
  • •prazosin (Minipress)
  • •terazosin (Hytrin)
  • •Any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician

Arms & Interventions

5mg tadalafil once daily for 14 days

Intervention: Tadalafil 5mg (Drug)

Outcomes

Primary Outcomes

Change in maximal voluntary contraction of lower leg.

Time Frame: 14 days

Lower leg strength using a dynamometer; performed both before and after 14 days of tadalafil

Secondary Outcomes

  • Change in muscle Fatigue(14 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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