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

August 30, 2016 updated by: Indiana University
Studies of myocardial fuel selection using a novel palmitate-based PET probe

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Hospital GCRC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: thiapalmitate tracer
Radiolabeled tracer infusion; occurs in all treatment arms
Other Names:
  • 16- 18-F-fluoro-4-thiapalmitate
Drug: Saline
Saline infusion for control
Experimental: 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).
Drug: thiapalmitate tracer
Radiolabeled tracer infusion; occurs in all treatment arms
Other Names:
  • 16- 18-F-fluoro-4-thiapalmitate
Drug: Insulin
Insulin infusion for insulin/glucose clamp procedure

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

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

Investigators

  • Principal Investigator: Kieren J Mather, MD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

September 29, 2015

First Submitted That Met QC Criteria

September 29, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Estimate)

August 31, 2016

Last Update Submitted That Met QC Criteria

August 30, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10100002643
  • R21DK071142 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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