Impact of Muscle Fat Accumulation on the Genomic Profile... | NCT02187965

Studies
Impact of Muscle Fat Accumulation on the Genomic Profile of Skeletal Muscle in Older Adults

NCT02187965

Sponsor

Purdue University

Status

Completed

Last Update Posted

Jul 11, 2014Estimated

Enrollment

11Actual

Phase

Not provided

Conditions

Intermuscular Adipose Tissue Quantification

Interventions

Not provided

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

Aug 2011

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

Aug 2011

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Jul 9, 2014

First Submission Date that Met QC Criteria

Jul 10, 2014

First Posted Date

Jul 11, 2014Estimated

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

Jul 10, 2014

Last Update Posted Date

Jul 11, 2014Estimated

Description Module

Brief Summary

Subjects were asked to come to the Purdue facilities after an overnight fast on 2 different testing days for 2.5 hours each day. On one day the subjects participated in blood pressure and body weight measurements as well as a muscle biopsy from the thigh. On the second day the subjects underwent an MRI and MRS scan of the thigh and calf.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

11Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MRI	To determine the within day reproducibility of MRI scans for intermuscular adipose tissue (IMAT) quantification in older men and women.	1 day

Secondary Outcomes

Measure	Description	Time Frame
genomic profile	To examine the influence of IMAT accumulation on the genomic profile of skeletal muscle of normal weight or obese adults.	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

60-80 years old, men and women, normal body weight or obese,

Exclusion Criteria:

Certain medical conditions could have placed them at risk

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

normal weight and obese older adults

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Purdue University		West Lafayette	Indiana	47906	United States