Mapping Human Muscle Satellite Cell Fate By Real-Time Ima... | NCT02685319

Studies
Mapping Human Muscle Satellite Cell Fate By Real-Time Imaging

NCT02685319

Sponsor

Purdue University

Status

Completed

Last Update Posted

Jun 20, 2017Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Flaccid Muscle Tone

Interventions

muscle biopsy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

May 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Feb 10, 2016

First Submission Date that Met QC Criteria

Feb 12, 2016

First Posted Date

Feb 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2017

Last Update Posted Date

Jun 20, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
muscle biopsy	Experimental	a muscle sample will be taken from the mid-thigh (Vastus Lateralis) and analyzed	Procedure: muscle biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
muscle biopsy	Procedure	a muscle sample will be taken from the mid-thigh (Vastus Lateralis) and analyzed	muscle biopsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	<10 hrs

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

-Inclusion Criteria:

men 20-29 yrs
BMI between 20 and 34.9
Fasting Glucose <110 mg/dL
Blood Pressure <160/100mm Hg
Non-Diabetic
LDL-Cholesterol <160mg/dL
Triacylglycerol <400 mg/dL
Makers of kidney, liver, and heart functions within 10% of clinical normalcy
<1.5hr /wk of habitual aerobic exercise training and no resistance exercise training in the past 6 months

Exclusion Criteria:

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
- 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

29 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Wayne W Campbell, Ph.D.	Purdue University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Purdue University - Stone Hall 700 W State St		West Lafayette	Indiana	47907	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009123	Muscle Hypotonia

Ancestor Terms

ID	Term
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided