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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05458232
• Other study ID #: 273780
• Status: Withdrawn
• Start date: January 20, 2023
• Est. completion date: January 20, 2023

Study information

• Verified date: December 2022
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 20, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Drug:
• Tadalafil 5mg
Subjects will ingest one 5mg tablet of tadalafil each evening for 14 days.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rosenberg IH. Sarcopenia: origins and clinical relevance. J Nutr. 1997 May;127(5 Suppl):990S-991S. doi: 10.1093/jn/127.5.990S. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in maximal voluntary contraction of lower leg.	Lower leg strength using a dynamometer; performed both before and after 14 days of tadalafil.	14 days
Secondary	Change in muscle Fatigue	A test of lower leg muscular endurance using a dynamometer; performed both before and after 14 consecutive days of tadalafil.	14 days