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

Completed

Conditions studied: Diabetes, Obesity

In brief

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.

Key facts

Study ID

NCT00222885

Run by

University of Pittsburgh

People needed

50

Starts

2002-12-01

Expected to finish

2006-12-01

Last updated by the study team

2007-12-19

Who can join

Age: 20 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• We will recruit normal weight (BMI 19 to 25 kg/m2), glucose tolerant, healthy volunteers, who are between the ages of 20 and 45 years old. Volunteers for this study must have a fasting glucose < 100 mg/dl; HbA1c < 6.0; Hct > 34; ALT < 60; AST < 60; Alk phos < 150; TSH < 8; Trig < 300; Chol < 250; systolic BP < 150; diastolic BP < 95; negative family history (first-degree relatives) for type 2 DM; be in good health and not be taking any chronic medications. Previous difficulty with xylocaine will be an exclusion. To be eligible for these studies, volunteers must be free of clinical evidence of cardiac, renal, hepatic, and vascular disease, or other major medical problems that would endanger the volunteers or compromise the scientific validity of the studies. Subjects with a history of myocardial infarction, proteinuria (defined as 1+ protein), liver disease, alcohol or drug abuse, malignancy or neuromuscular disease will be excluded.

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.

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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