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

NCT ID: NCT05458232

Last Updated: 2024-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-20

Study Completion Date

2023-01-20

Brief Summary

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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

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Conditions

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Sarcopenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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5mg tadalafil once daily for 14 days

Tadalafil 5mg

Intervention Type DRUG

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

Interventions

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Tadalafil 5mg

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND
PMID: 9164280 (View on PubMed)

Other Identifiers

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273780

Identifier Type: -

Identifier Source: org_study_id

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