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CompletedNCT01698424Updated Jan 13, 2015

PET/CT of Skeletal Muscle Amino Acid Kinetics

An observational study in Sarcopenia, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to female participants aged 65 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-13.

Sponsored by University of California, San Francisco · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
12
Ages
65 Years to 80 Years
Sex
Female
01

Study 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.

Read the detailed description

On 2 separate visits, with approximately 2 weeks in between visits. For each visit the volunteer will be required to fast overnight (no food or drink for 10 hours prior to arrival at UCSF (water is OK)).

Visit 1 will last approximately 5-6 hours. Visit 2 will last approximately 8 hours. Each visit will include the same general procedures, with the second visit varying slightly from the first (described below). Including the 10-hour overnight fast, both visits will entail roughly 15 hours of continuous fasting. After completion of Visit 1, snacks and drinks will be available. For Visit 2, the volunteer will have a protein drink roughly 4-5 hours into the visit, and snacks and drinks will be made available when the visit is over.

After checking in, the volunteer will be admitted to the Imaging Suite. i) Catheters At the beginning of each visit, a nurse will place two flexible plastic catheters in veins in the forearms. The catheters will be used to collect blood samples to measure changes in hormone and amino acid levels. They will stay in place for 5 hours. One of the catheters will also be used to infuse stable isotopes.

ii) Stable Isotopes Stable isotopes of amino acids are naturally occurring and are not radioactive. Stable isotopes are very similar to regular amino acids, except that they are a slightly heavier form (e.g., "heavy water" is a stable isotope of regular water). Stable isotopes are already present in very small quantities in your body. For 5 hours (6am - 11am), we will infuse stable isotopes into a forearm vein to increase the naturally occurring level by 7-10%. We will later be able to measure this change using highly sophisticated instruments. This will allow us to calculate the rate at which body builds muscle.

iii) Muscle Biopsies During each of the visits, we will have either 2 or 3 muscle biopsy samples taken directly from 2 small incisions in the muscle of the thigh. On visit 1, we will have biopsies at 2 time points and on visit 2 there will be 3 biopsies. The muscle biopsy procedure involves the taking of a small piece of muscle tissue from the outside of the upper leg, about 4-6 inches above the knee. The skin is cleaned and injected with local anesthetic (lidocaine, a numbing medicine) to minimize any pain. A small incision about 1 cm will be made in the skin, through which a needle about 0.8 cm is advanced into the muscle. A piece of the muscle is then removed with the needle, the skin is closed with a special medical glue or suture, a dressing is applied and pressure on the biopsy site held for about 10 minutes to stop any bleeding that might occur. The leg is then wrapped in an ACE bandage to prevent any bleeding that might occur.

iv) PET/CT Scan In between the biopsies, the volunteer will be injected into a vein with a dose (12.5 millicurie) of L-[methyl-11C]methionine (11C-MET) to begin the PET/CT imaging. Like the stable isotope talked about in section "ii" above, methionine is a naturally occurring amino acid in the body. However, the form of methionine is radioactive (this allows the scanner to detect its presence in your body). The PET/CT will take detailed pictures of the flow of 11C-MET into the muscles of the legs, which will provide information about new muscle protein being formed. The volunteer will need to lie still on a table with the thighs inside the machine. The table will move and the machine will make clicking and whirring noises as the pictures are taken. It will take about 90 minutes to gather the scan data.

v) Ingestion of protein drink Towards the middle of the 2nd visit, the volunteer will be asked to drink approximately 8 fluid ounces of a drink that contains 15 grams of protein.

02

Conditions studied

  • Sarcopenia

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03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 401 are open to participants now.

This study's enrollment of 12 is below the median of 120 across 419 observational studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Healthy women

Inclusion criteria

  • Healthy women
  • age 65-80 years old

Exclusion criteria

Exclusion Criteria:

  • with any musculoskeletal disorders
  • with any metabolic disorders
  • blood thinning medications
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
12 participants (actual)
Biospecimen retention
Samples without dna
06

What researchers measure

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

    Time frame: 12 months

07

Study locations

1 site
  • Imaging Center-Department of Radiology, UCSF
    San Francisco, California 94107, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01698424
Lead sponsor
University of California, San Francisco
Collaborators
University of Texas
Responsible party
Sponsor
First posted
Oct 3, 2012
Start date
Jun 2013
Primary completion
Aug 2014
Completion
Sep 2014
Last update
Jan 13, 2015

Study contacts

Thomas Lang, PhD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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