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PET/CT of Skeletal Muscle Amino Acid Kinetics

9 januari 2015 uppdaterad av: University of California, San Francisco
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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

12

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • California
      • San Francisco, California, Förenta staterna, 94107
        • Imaging Center-Department of Radiology, UCSF

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

65 år till 80 år (Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Testmetod

Sannolikhetsprov

Studera befolkning

Healthy women

Beskrivning

Inclusion Criteria:

  • Healthy women
  • age 65-80 years old

Exclusion Criteria:

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Determining skeletal muscle Protein synthesis rates, PSR
Tidsram: 12 months
protein synthesis rates as measured by both 11C-MET PET/CT and 13C-Phe uptake
12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Samarbetspartners

Utredare

  • Huvudutredare: Thomas Lang, PhD, University of California, San Francisco

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juni 2013

Primärt slutförande (Faktisk)

1 augusti 2014

Avslutad studie (Faktisk)

1 september 2014

Studieregistreringsdatum

Först inskickad

21 september 2012

Först inskickad som uppfyllde QC-kriterierna

28 september 2012

Första postat (Uppskatta)

3 oktober 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

13 januari 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 januari 2015

Senast verifierad

1 januari 2015

Mer information

Termer relaterade till denna studie

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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