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

NCT05458232 | Withdrawn FDA Drug

• 1 other identifier: 273780
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in muscle Fatigue

  14 days

Study Arms (1)

5mg tadalafil once daily for 14 days

Drug: Tadalafil 5mg

Interventions

Tadalafil 5mg DRUG

Subjects will ingest one 5mg tablet of tadalafil each evening for 14 days.

5mg tadalafil once daily for 14 days

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males 60-75 years who have been prescribed 5mg daily tadalafil by their physician.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related 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.

  PMID: 9164280 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood/plasma.

MeSH Terms

Conditions

Sarcopenia

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: January 20, 2023
• Primary Completion: January 20, 2023
• Study Completion: January 20, 2023
• Last Updated: November 4, 2024

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)