Multi-Tracer PET Quantitation of Insulin Action in Muscle (Phase 1, Phase 2, Phase 3, Phase 4)

NCT00222885 | Completed

• 2 other identifiers: 011178R01DK060555
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Obesity

Keywords

PET imaging; Skeletal muscle; In vivo insulin-stimulated tissue perfusion; Glucose transport; Glucose phosphorylation

Outcome Measures

Primary Outcomes (1)

• Triple tracer PET method development for in vivo imaging of skeletal muscle metabolism

Secondary Outcomes (1)

• Testing of mathematical modeling of PET data

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Subjects will be excluded if taking chronic medications known to adversely affect glucose homeostasis including thiazide diuretics, oral glucocorticoids, nicotinic acid, and beta-blockers. Subjects who have gained or lost more than 3 kg during the past 6 months will be excluded. Because of the PET scanning, all premenopausal women must have a negative pregnancy test within 24 hours prior to these procedures and this will be confirmed prior to each PET scanning session. These subjects will also be advised to use reliable contraceptive techniques during the study period. To avoid radiation exposure of the infant, women who are currently breastfeeding will not be permitted to participate in this research study. Subjects participating in Phase 2 and Phase 4 (that includes an MRI Scan) will be excluded if they have a contraindication to MRI such as surgical or vascular implants, pregnancy, pacemaker, or claustrophobia. In subjects with a questionable history of metallic fragments, an X-ray of the suspected area of the body will be performed to rule such out.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Bertoldo A, Price J, Mathis C, Mason S, Holt D, Kelley C, Cobelli C, Kelley DE. Quantitative assessment of glucose transport in human skeletal muscle: dynamic positron emission tomography imaging of [O-methyl-11C]3-O-methyl-D-glucose. J Clin Endocrinol Metab. 2005 Mar;90(3):1752-9. doi: 10.1210/jc.2004-1092. Epub 2004 Dec 21.

  PMID: 15613423 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Obesity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David E Kelley, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: December 1, 2002
• Study Completion: December 1, 2006
• Last Updated: December 19, 2007

Record last verified: 2007-12

Locations

US (1)