Viewing Study NCT00222885



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Study NCT ID: NCT00222885
Status: COMPLETED
Last Update Posted: 2007-12-19
First Post: 2005-09-20

Brief Title: Multi-Tracer PET Quantitation of Insulin Action in Muscle Phase 1 Phase 2 Phase 3 Phase 4
Sponsor: University of Pittsburgh
Organization: University of Pittsburgh

Study Overview

Official Title: Three-Tracer PET Quantitation of Insulin Action in Muscle
Status: COMPLETED
Status Verified Date: 2007-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this research is to develop a new method to study insulin action using positron emission tomography PET Insulin is the hormone made by your body to control the blood sugar level We want to develop a way to image look at the following three things 1 how insulin affects blood flow in skeletal muscle 2 how insulin affects glucose sugar transport movement into muscle and 3 how insulin affects glucose metabolism breakdown in skeletal muscle of healthy individuals The long term goal will be to later apply this method to the study of metabolic diseases especially type 2 diabetes mellitus and obesity

PET imaging is a relatively non-invasive way to obtain a metabolic picture of body organs and has been used successfully to study brain heart and more recently skeletal muscle In this research study we will use PET with as many as four radioactive tracers markers to study skeletal muscle glucose transport in healthy volunteers
Detailed Description: The goal of this proposal is to develop a novel triple-tracer positron emission tomography PET method to image in vivo insulin-stimulated tissue perfusion glucose transport and glucose phosphorylation in skeletal muscle in healthy individuals The long term goal will be to later apply this model to the study of metabolic diseases notably type 2 diabetes mellitus Type 2 DM and obesity Ob While it is often suggested that glucose transport is the rate-controlling step for insulin action we will test the hypothesis that the control insulin exerts on the uptake of glucose into skeletal muscle is distributed across flow and tissue perfusion trans-membrane transport and intra-cellular phosphorylation of glucose

Specific Aim 1 The first specific aim is to develop the triple-tracer PET method for quantitative determinations of tissue perfusion glucose transport and glucose phosphorylation in skeletal muscle To measure blood flow and tissue perfusion we will use 15O-H2O half-life 2 min also referred to as 15O-water To measure glucose transport we will use 11C-3-O-methyl glucose half-life 20 min also referred to as 3-0-MG an analog that is transported but not phosphorylated or otherwise metabolized 18F-2-deoxy-2-fluoro-glucose half-life 109 min also referred to as FDG will be used to examine glucose transport and glucose phosphorylation Because of the differences in half-life of the three positrons 15O 11C and 18F it is feasible to use each of these tracers in sequence in the same individual

Specific Aim 2 The second specific aim is to rigorously test mathematical models to extract quantitative physiological information from dynamic PET imaging We will test a novel model that specifically addresses the kinetics of substrate delivery within the interstitial space of skeletal muscle ie a 5 rate constant 4 compartment model with respect to FDG Model testing will entail use of non-compartmental models eg spectral analysis

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01DK060555 NIH None httpsreporternihgovquickSearchR01DK060555