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

Withdrawn

• Conditions: Sarcopenia
• Interventions: Drug: Tadalafil 5mg

• Registration Number: NCT05458232
• Lead Sponsor: University of Arkansas

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-11
• Study First Posted: 2022-07-14
• Status Verified: 2022-12
• Study Start: 2023-01-20
• Primary Completion: 2023-01-20
• Study Completion: 2023-01-20
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
5mg tadalafil once daily for 14 days	Tadalafil 5mg	-

Primary Outcome Measures

Name	Time	Method
Change in maximal voluntary contraction of lower leg.	14 days	Lower leg strength using a dynamometer; performed both before and after 14 days of tadalafil

Secondary Outcome Measures

Name	Time	Method
Change in muscle Fatigue	14 days	A test of lower leg muscular endurance using a dynamometer; performed both before and after 14 consecutive days of tadalafil.

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States