Back to resultsA Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
thiapalmitate tracer
Saline
Insulin
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes Mellitus
Eligibility 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
Sites / Locations
- Indiana University Hospital GCRC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Saline
Insulin Clamp
Arm 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).
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).
Outcomes
Primary Outcome Measures
Myocardial Fatty Acid Uptake Rate
PET measure of fatty acid uptake rate
Secondary Outcome Measures
Myocardial Oxidation Rate
PET measure of total oxidation rate
Myocardial Perfusion Rate
PET measure of total myocardial perfusion (blood flow)
Full Information
NCT ID
NCT02563834
First Posted
September 29, 2015
Last Updated
August 30, 2016
Sponsor
Indiana University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT02563834
Brief Title
A Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism
Official Title
A Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saline
Arm Type
Experimental
Arm 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).
Arm Title
Insulin Clamp
Arm Type
Experimental
Arm 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).
Intervention Type
Drug
Intervention Name(s)
thiapalmitate tracer
Other Intervention Name(s)
16- 18-F-fluoro-4-thiapalmitate
Intervention Description
Radiolabeled tracer infusion; occurs in all treatment arms
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Saline infusion for control
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Insulin infusion for insulin/glucose clamp procedure
Primary Outcome Measure Information:
Title
Myocardial Fatty Acid Uptake Rate
Description
PET measure of fatty acid uptake rate
Time Frame
4 Hours
Secondary Outcome Measure Information:
Title
Myocardial Oxidation Rate
Description
PET measure of total oxidation rate
Time Frame
4 Hours
Title
Myocardial Perfusion Rate
Description
PET measure of total myocardial perfusion (blood flow)
Time Frame
4 Hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kieren J Mather, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Hospital GCRC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26732686
Citation
Mather KJ, Hutchins GD, Perry K, Territo W, Chisholm R, Acton A, Glick-Wilson B, Considine RV, Moberly S, DeGrado TR. Assessment of myocardial metabolic flexibility and work efficiency in human type 2 diabetes using 16-[18F]fluoro-4-thiapalmitate, a novel PET fatty acid tracer. Am J Physiol Endocrinol Metab. 2016 Mar 15;310(6):E452-60. doi: 10.1152/ajpendo.00437.2015. Epub 2016 Jan 5.
Results Reference
result
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A Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism
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