PET Imaging of Regional Variation in Insulin Sensitivity of Adipose Tissue in Humans
Three-Tracer PET Quantitation of Insulin Action in Muscle
2 other identifiers
observational
20
1 country
1
Brief Summary
The purpose of this research study is to use a relatively new technology, called Positron Emission Tomography (PET), to study how insulin works on sugar in your body's fatty tissue. PET imaging is a way of obtaining a "metabolic image" of your internal organs. It does not involve surgery and is not a high risk process. It has been used successfully to study brain, heart and more recently, skeletal muscle. In this research study, we will use PET in combination with Magnetic Resonance Imaging (MRI), to study fatty tissues in healthy people who do not have diabetes. In the future, we plan to do similar PET/MRI studies in individuals with type 2 diabetes mellitus (T2DM) and in individuals who are likely to develop T2DM. Fat tissue might have a lot to do with developing type 2 diabetes. First, it is well recognized that excess fatty tissues, especially the kind in your belly, increases risk for the development of T2DM, as well as affecting other ways the body uses insulin. Second, fatty tissue is a classic target tissue for the action of insulin, which regulates the use of sugar by fat cells and also regulates the release of fatty acids from fatty tissues. Third, studies in mice that lack fatty tissue, indicate that severe insulin resistance (lack of a normal response to insulin) can result. Other types of studies have shown that fatty tissues make proteins that affect your body's insulin and your appetite in good and bad ways. Yet despite this importance, we still lack techniques for the study of fatty tissue metabolism in humans.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 19, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFebruary 18, 2008
February 1, 2008
September 19, 2005
February 15, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Method development of dose-responsive measurement of insulin-stimulated glucose uptake of adipose tissue using 18-FDG and Positron Emission Tomography
Secondary Outcomes (1)
To assess regional variation in insulin-stimulated glucose uptake in adipose tissue.
Eligibility Criteria
You may qualify if:
- A thorough medical examination will be done at the screening examination. 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.
- We will recruit 20 volunteers (10 men and 10 women), non-obese (BMI 20 to 27 kg/m2), glucose tolerant, healthy volunteers, who are between the ages of 25 and 45 years old. Volunteers for this study must have a fasting glucose \< 100 mg/dl; HbA1c \< 5.7%; Hct \> 34; fasting plasma insulin level \< 12 µU/ml; ALT \< 60; AST \< 60; Alk phos \< 150; TSH \< 6; Trig \< 150 mg/dl; Chol \< 250; systolic BP \< 140; diastolic BP \< 90; negative family history (first-degree relatives) for type 2 DM; be in good health and not be taking any chronic medications known to affect adipose tissue metabolism or insulin sensitivity (e.g. glucocorticoids, thiazide diuretics).
You may not qualify if:
- Pregnant women and women who are currently breast-feeding will be excluded from study participation. Women will be checked for pregnancy (using a urine pregnancy test) at screening, within 24 hours prior to the DEXA scan and within 24 hours prior to each PET and MRI study. Previous difficulty with xylocaine or claustrophobia will exclude.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David E. Kelley, MD
University of Pittsburgh
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 19, 2005
First Posted
September 22, 2005
Study Start
April 1, 2005
Study Completion
December 1, 2006
Last Updated
February 18, 2008
Record last verified: 2008-02