SarcopeniaNCT05458232
Use of a Phosphodiesterase Type 5 Inhibitor to Improve Anabolic Resistance in Older Adults
An observational study of Sarcopenia, run by University of Arkansas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 to 75 years, men only
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Tadalafil 5mg
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2023to 20 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Males 60-75 years who have been prescribed 5mg daily tadalafil by their physician.
Who may be able to join
- Ages 60-75 yrs
- Recently prescribed 5mg of tadalafil daily for clinical purposes
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
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
- Being tested
- Tadalafil 5mg
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 5mgDrug
Subjects will ingest one 5mg tablet of tadalafil each evening for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| 5mg tadalafil once daily for 14 days | Not described Receives: Drug: Tadalafil 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal voluntary contraction of lower leg.
Lower leg strength using a dynamometer; performed both before and after 14 days of tadalafil
Measured: 14 days
Secondary outcomes (1)
Change in muscle Fatigue
A test of lower leg muscular endurance using a dynamometer; performed both before and after 14 consecutive days of tadalafil.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start20 Jan 2023
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
Why it stopped: No subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458232
- Sponsor's protocol ID
- 273780
- Status last verified
- Dec 2022
- First submitted
- 11 Jul 2022
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosenberg IH. Sarcopenia: origins and clinical relevance. J Nutr. 1997 May;127(5 Suppl):990S-991S. doi: 10.1093/jn/127.5.990S.
PubMed 9164280
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Phosphodiesterase Type 5 Inhibitor to Improve Anabolic Resistance in Older Adults
- ClinicalTrials.gov ID
- NCT05458232
- Acronym / sponsor ID
- 273780
- Conditions
- Sarcopenia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5mg tadalafil once daily for 14 days | – | Drug: Tadalafil 5mg |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males 60-75 years who have been prescribed 5mg daily tadalafil by their physician.
Key inclusion criteria (2 listed)
- Ages 60-75 yrs
- Recently prescribed 5mg of tadalafil daily for clinical purposes
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tadalafil 5mgSubjects will ingest one 5mg tablet of tadalafil each evening for 14 days. | Drug | 5mg tadalafil once daily for 14 days |
Primary outcome
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
1 secondary outcome
Change in muscle Fatigue
Time frame: 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Background: PubMed 9164280Rosenberg IH. Sarcopenia: origins and clinical relevance. J Nutr. 1997 May;127(5 Suppl):990S-991S. doi: 10.1093/jn/127.5.990S.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximal voluntary contraction of lower leg. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05458232, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.