Flaccid Muscle ToneS48NCT02685319
Mapping Human Muscle Satellite Cell Fate By Real-Time Imaging
A study testing muscle biopsy in people with Flaccid Muscle Tone, run by Purdue University at 1 site in United States.
Trial summary
Mapping Human Muscle Satellite Cell Fate By Real-Time Imaging Read more about this study
- Who is it for?
- Ages 20 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Flaccid Muscle Tone
- What is being tested?
- muscle biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Jun 2016
- Phase
- Interventional
- 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 20 to 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- men <20or>29 yrs
- BMI between <20 and >34.9
- Fasting Glucose >110 mg/dL
- Blood Pressure >160/100mm Hg
- Non-Diabetic
- LDL-Cholesterol >160mg/dL
Show all 10Show fewer
- Triacylglycerol >400 mg/dL
- Pre-existing kidney or liver conditions
- -->1.5hr /wk of habitual aerobic exercise training and no resistance exercise training in the past 6 months
- Currently taking prescribed blood thinners
Trial locations and contacts
1 site in 1 country.
United States1 site
Purdue University - Stone Hall 700 W State St
West Lafayette, Indiana, 47907
About this study
Official title: Mapping Human Muscle Satellite Cell Fate By Real-Time
Mapping Human Muscle Satellite Cell Fate By Real-Time Imaging
Read the detailed description
The aim of this study is to obtain human muscle samples for cell culturing to analyze muscle cell development in real-time to uncover factors that influence growth.
- Conditions
- Flaccid Muscle Tone
- Being tested
- muscle biopsy
- Medical subject headings
- Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle biopsyProcedure or surgery
a muscle sample will be taken from the mid-thigh (Vastus Lateralis) and analyzed
| Study group | Role | What they receive |
|---|---|---|
| muscle biopsy | Experimental | a muscle sample will be taken from the mid-thigh (Vastus Lateralis) and analyzed Receives: Procedure: muscle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mapping Human Muscle Satellite Cell Fate By Real-Time Imaging
this study is to obtain human muscle samples for cell culturing which will be exposed to a novel real-time imaging technique in order to elucidate factors that influence muscle satellite cell growth.
Measured: <10 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flaccid Muscle ToneStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Campbell, Purdue University
- Investigators
- Wayne W Campbell, Ph.D., Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685319
- Sponsor's protocol ID
- 1512016862
- Acronym
- S48
- Status last verified
- Jun 2017
- First submitted
- 10 Feb 2016
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping Human Muscle Satellite Cell Fate By Real-Time
- ClinicalTrials.gov ID
- NCT02685319
- Acronym / sponsor ID
- S48 / 1512016862
- Conditions
- Flaccid Muscle Tone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 18 Feb 2016 (estimated)
- 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.
Mapping Human Muscle Satellite Cell Fate By Real-Time Imaging
Detailed description
The aim of this study is to obtain human muscle samples for cell culturing to analyze muscle cell development in real-time to uncover factors that influence growth.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| muscle biopsy | Experimental | Procedure: muscle biopsya muscle sample will be taken from the mid-thigh (Vastus Lateralis) and analyzed |
Who may qualify
- Ages
- 20 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- men <20or>29 yrs
- -->1.5hr /wk of habitual aerobic exercise training and no resistance exercise training in the past 6 months
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 |
|---|---|---|
| muscle biopsya muscle sample will be taken from the mid-thigh (Vastus Lateralis) and analyzed | Procedure or surgery | muscle biopsy |
Primary outcome
Mapping Human Muscle Satellite Cell Fate By Real-Time Imaging
Time frame: <10 hrs
this study is to obtain human muscle samples for cell culturing which will be exposed to a novel real-time imaging technique in order to elucidate factors that influence muscle satellite cell growth.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Individual participant dataSharing planned: No
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.
Wayne W Campbell, Ph.D. principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing muscle biopsy in people with Flaccid Muscle Tone, run by Purdue University 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 0 inclusion and 10 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: finished, as of the sponsor's last update on 20 Jun 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mapping Human Muscle Satellite Cell Fate By Real-Time Imaging (time frame: <10 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2017.