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

January 26, 2023 updated by: University of Arkansas
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
5mg tadalafil once daily for 14 days
Drug: Tadalafil 5mg
Subjects will ingest one 5mg tablet of tadalafil each evening for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in maximal voluntary contraction of lower leg.
Time Frame: 14 days
Lower leg strength using a dynamometer; performed both before and after 14 days of tadalafil.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in muscle Fatigue
Time Frame: 14 days
A test of lower leg muscular endurance using a dynamometer; performed both before and after 14 consecutive days of tadalafil.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2023

Primary Completion (Actual)

January 20, 2023

Study Completion (Actual)

January 20, 2023

Study Registration Dates

First Submitted

July 11, 2022

First Submitted That Met QC Criteria

July 11, 2022

First Posted (Actual)

July 14, 2022

Study Record Updates

Last Update Posted (Estimate)

January 30, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 273780

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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