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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: thiapalmitate tracer; Drug: Saline; Drug: Insulin

• Registration Number: NCT02563834
• Lead Sponsor: Indiana University

Brief Summary

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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2015-09-29
• Study First Submitted QC: 2015-09-29
• Study First Posted: 2015-09-30
• Results First Submitted: 2016-02-29
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-30
• Last Update Submitted: 2016-08-30
• Results First Posted: 2016-08-31
• Last Update Posted: 2016-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline	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).
Insulin Clamp	thiapalmitate tracer	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).
Saline	thiapalmitate tracer	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).
Insulin Clamp	Insulin	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).

Primary Outcome Measures

Name	Time	Method
Myocardial Fatty Acid Uptake Rate	4 Hours	PET measure of fatty acid uptake rate

Secondary Outcome Measures

Name	Time	Method
Myocardial Perfusion Rate	4 Hours	PET measure of total myocardial perfusion (blood flow)
Myocardial Oxidation Rate	4 Hours	PET measure of total oxidation rate

Trial Locations

Locations (1)

Indiana University Hospital GCRC; 🇺🇸 Indianapolis, Indiana, United States