A Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism

Study Overview
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Brief Summary
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Studies of myocardial fuel selection using a novel palmitate-based PET probe

Detailed Description
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A novel Positron Emission Tomography (PET) probe, 16- 18-F-fluoro-4-thiapalmitate, will be used to evaluate myocardial atty acid uptake. Studies will be done in humans with type 2 diabetes mellitus, and in controls. Studies will take place on 2 separate days, under fasting conditions and under insulin clamp conditions.

Official Title
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A Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: thiapalmitate tracer
* Drug: Saline
* Drug: Insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lean: BMI<25 kg/m2 normal glucose tolerance by 75g oral glucose tolerance test Type 2 diabetes mellitus: BMI >25 kg/m2 previously diagnosed type 2 diabetes mellitus on oral and/or injected insulin treatment. Exclusion Criteria: Lean: *Use of any chronic medications Type 2 diabetes mellitus known microvascular disease known coronary or other macro vascular disease use of PPARgamma class antidiabetic agents within 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Saline<br>Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate). | Drug: thiapalmitate tracer<br>* Radiolabeled tracer infusion; occurs in all treatment arms<br>* Other names: 16- 18-F-fluoro-4-thiapalmitate;Drug: Saline<br>* Saline infusion for control<br>|
| Experimental: Insulin Clamp<br>Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate). | Drug: thiapalmitate tracer<br>* Radiolabeled tracer infusion; occurs in all treatment arms<br>* Other names: 16- 18-F-fluoro-4-thiapalmitate;Drug: Insulin<br>* Insulin infusion for insulin/glucose clamp procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial Fatty Acid Uptake Rate | PET measure of fatty acid uptake rate | 4 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial Oxidation Rate | PET measure of total oxidation rate | 4 Hours | 
| Myocardial Perfusion Rate | PET measure of total myocardial perfusion (blood flow) | 4 Hours |