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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-06-30

Brief Summary

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Studies of myocardial fuel selection using a novel palmitate-based PET probe

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Saline

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).

Group Type EXPERIMENTAL

thiapalmitate tracer

Intervention Type DRUG

Radiolabeled tracer infusion; occurs in all treatment arms

Saline

Intervention Type DRUG

Saline infusion for control

Insulin Clamp

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).

Group Type EXPERIMENTAL

thiapalmitate tracer

Intervention Type DRUG

Radiolabeled tracer infusion; occurs in all treatment arms

Insulin

Intervention Type DRUG

Insulin infusion for insulin/glucose clamp procedure

Interventions

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thiapalmitate tracer

Radiolabeled tracer infusion; occurs in all treatment arms

Intervention Type DRUG

Saline

Saline infusion for control

Intervention Type DRUG

Insulin

Insulin infusion for insulin/glucose clamp procedure

Intervention Type DRUG

Other Intervention Names

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16- 18-F-fluoro-4-thiapalmitate

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes