Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02563834
Recruitment Status : Completed
First Posted : September 30, 2015
Results First Posted : August 31, 2016
Last Update Posted : August 31, 2016
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Indiana University

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: thiapalmitate tracer Drug: Saline Drug: Insulin Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism
Study Start Date : January 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 16- 18-F-fluoro-4-thiapalmitate

Drug: Insulin
Insulin infusion for insulin/glucose clamp procedure




Primary Outcome Measures :
  1. Myocardial Fatty Acid Uptake Rate [ Time Frame: 4 Hours ]
    PET measure of fatty acid uptake rate


Secondary Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563834


Locations
Layout table for location information
United States, Indiana
Indiana University Hospital GCRC
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: Kieren J Mather, MD Indiana University
Publications of Results:
Layout table for additonal information
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT02563834    
Other Study ID Numbers: 10100002643
R21DK071142 ( U.S. NIH Grant/Contract )
First Posted: September 30, 2015    Key Record Dates
Results First Posted: August 31, 2016
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs