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

University of Arkansas

Status: Withdrawn

Conditions: Sarcopenia

Treatments: Drug: Tadalafil 5mg

Study type: Observational

Funder types: Other

Identifiers

NCT05458232

273780

Details and patient eligibility

About

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.

Sex: Male

Ages: 60 to 75 years old

Volunteers: No Healthy Volunteers

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 3.

• 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

Trial design

0 participants in 1 patient group

5mg tadalafil once daily for 14 days

Treatment:

Drug: Tadalafil 5mg