Multi-Tracer PET Quantitation of Skeletal Muscle Insulin Resistance in Type 2 Diabetes Mellitus

NCT00222781 | Completed

• 2 other identifiers: 0311010R01DK060555
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to use a recently developed triple-tracer positron emission tomography (PET) method to study skeletal muscle insulin resistance. Insulin is the hormone made by your body to control the blood sugar level. "Resistance' to insulin could cause poor blood glucose control (blood sugar levels that are higher than normal). We want to use this new method 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. 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 three radioactive tracers (markers), to study skeletal muscle glucose transport in individuals with type 2 diabetes mellitus (type 2 DM) and in non-diabetic individuals who are either normal weight or overweight/obese

Conditions

Diabetes; Obesity

Keywords

Skeletal muscle; Triple-tracer PET imaging

Outcome Measures

Primary Outcomes (1)

• Compare triple tracer PET imaging of skeletal muscle in lean, obese and T2DM

Secondary Outcomes (1)

• Mathematical modeling of PET data.

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• We will recruit eight normal weight (BMI 19 to 25 kg/m2), and eight overweight or obese (BMI 27 to 38 kg/m2), non-diabetic, healthy volunteers, who are between the ages of 30 to 55 years old. For scientific reasons it is crucial that the groups are age matched. Limiting the age range to a period of 25 years will help achieve this goal. Volunteers for these two groups must have a fasting glucose \< 110 mg/dl; HbA1c \< 6.0%; Hct \> 34; ALT \< 60; AST \< 60; Alk phos \< 150; sTSH \< 8; Trig \< 300; Chol \< 250; systolic BP \< 150; diastolic BP \< 95; and be in good health. A medical history and physical exam will be conducted by a nurse practitioner or a medical doctor.

You may not qualify if:

• We will exclude volunteers taking thiazolidinediones as the washout period for this class is uncertain, and exclude those taking insulin as withdrawal likely would cause unacceptable levels of hyperglycemia.
• Research volunteers with type 2 DM who are enrolled in the study and who are receiving oral diabetic agents (sulfonylureas, metformin or acarbose), will be instructed to withhold these medications for five days preceding both PET studies.

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

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 19, 2005
• First Posted: September 22, 2005
• Study Start: January 1, 2004
• Study Completion: December 1, 2006
• Last Updated: December 19, 2007

Record last verified: 2007-12

Locations

US (1)