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

Indiana University

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Saline; Drug: thiapalmitate tracer; Drug: Insulin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02563834

10100002643

R21DK071142 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Saline

Experimental group

Description:

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).

Treatment:

Drug: thiapalmitate tracer

Drug: Saline

Insulin Clamp

Experimental group

Description:

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).

Treatment:

Drug: thiapalmitate tracer

Drug: Insulin