Status:
COMPLETED
Multi-Tracer PET Quantitation of Insulin Action in Muscle (Phase 1, Phase 2, Phase 3, Phase 4)
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes
Obesity
Eligibility:
All Genders
20-45 years
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 ...
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 phosphorylat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
OBSERVATIONAL
End Date :
December 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00222885
Start Date
December 1 2002
End Date
December 1 2006
Last Update
December 19 2007
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213