NCT01698424

Brief Summary

Our goal is to develop and test a new imaging technique to help scientists study sarcopenia, the process by which muscle becomes weaker with age. This imaging technique uses Positron Emission Tomography/Computed Tomography (PET/CT) scanners to measure the ability of muscle to synthesize new protein. This ability to build new muscle protein is known as the Protein Synthesis Rate, and is thought to decline as people age and to contribute to muscle weakening. We are researching this technique in order to develop a tool to help scientists and physicians better understand how muscle ages and how it changes based on some stimulus, such as when people eat a high protein meal, exercise, or take muscle-building drugs. If our research is successful, it will provide a new method for scientists and physicians to test the effectiveness of new drugs and other treatments for muscle weakness. The study will look for healthy woman between the ages of 65 and 80.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2013

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

First Submitted

Initial submission to the registry

September 21, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

January 13, 2015

Status Verified

January 1, 2015

Enrollment Period

1.2 years

First QC Date

September 21, 2012

Last Update Submit

January 9, 2015

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

  • Determining skeletal muscle Protein synthesis rates, PSR

    protein synthesis rates as measured by both 11C-MET PET/CT and 13C-Phe uptake

    12 months

Eligibility Criteria

Age65 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy women

You may qualify if:

  • Healthy women
  • age 65-80 years old

You may not qualify if:

  • with any musculoskeletal disorders
  • with any metabolic disorders
  • blood thinning medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imaging Center-Department of Radiology, UCSF

San Francisco, California, 94107, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsies will be taken from upper thigh, Muscle tissue

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Thomas Lang, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2012

First Posted

October 3, 2012

Study Start

June 1, 2013

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

January 13, 2015

Record last verified: 2015-01

Locations

US(1)