NCT02685319

Brief Summary

Mapping Human Muscle Satellite Cell Fate By Real-Time Imaging

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

3 months

First QC Date

February 10, 2016

Last Update Submit

June 19, 2017

Conditions

Flaccid Muscle Tone

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

muscle biopsy

EXPERIMENTAL

a muscle sample will be taken from the mid-thigh (Vastus Lateralis) and analyzed

Procedure: muscle biopsy

Interventions

muscle biopsyPROCEDURE

a muscle sample will be taken from the mid-thigh (Vastus Lateralis) and analyzed

muscle biopsy

Eligibility Criteria

Age20 Years - 29 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University - Stone Hall 700 W State St

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Muscle Hypotonia

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wayne W Campbell, Ph.D.

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 10, 2016

First Posted

February 18, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

June 20, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)