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Completed

NCT Number: NCT02563834

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Hospital GCRC

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thiapalmitate tracer

Drug

Radiolabeled tracer infusion; occurs in all treatment arms

Other names: 16- 18-F-fluoro-4-thiapalmitate

Saline

Drug

Saline infusion for control

Insulin

Drug

Insulin infusion for insulin/glucose clamp procedure

Primary outcomes

  1. Myocardial Fatty Acid Uptake Rate

    Time frame: 4 Hours

    PET measure of fatty acid uptake rate

Secondary outcomes

  1. Myocardial Oxidation Rate

    Time frame: 4 Hours

    PET measure of total oxidation rate

  2. Myocardial Perfusion Rate

    Time frame: 4 Hours

    PET measure of total myocardial perfusion (blood flow)

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 30, 2015
Registry last updated
Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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