Type2 Diabetes

Obesity

0.9% saline infusion during cardiac PET-MRI scan with 11C-acetate

0.9% Sodium-chloride

0.9% saline infusion during cardiac PET-MRI scan with 18F-FDG

0.9% saline infusion during CMR scan (placebo). Followed by exenatide and glucagon infusion during cardiac PET-MRI scan with 11C-acetate. Followed by exenatide and glucagon infusion during CMR scan

Exenatide (50ng/min for 30 minutes loading followed by 25ng/min maintenance) and glucagon 12.5ng/kg/min

Exenatide and glucagon infusion during PET-MRI scan with 18F-FDG

Effect of Glucagon and Glucagon-like Peptide-1 Co-agonism on Cardiac Function and Metabolism in Overweight Participants With Type 2 Diabetes

A Pilot Study on the Effect of Glucagon and Glucagon-like Peptide-1 Co-agonism on Cardiac Function and Metabolism in Overweight Participants With Type 2 Diabetes (COCONUT)

Difference in myocardial perfusion between baseline/placebo scan and glucagon:exenatide scan as measured by 11C-acetate

Difference in myocardial efficiency between baseline/placebo scan and glucagon:exenatide scan (%)

Difference in myocardial oxygen consumption between baseline/placebo scan and glucagon:exenatide scan as measured by 11C-acetate

Difference in cardiac work between baseline/placebo scan and glucagon:exenatide scan

Difference in myocardial glucose uptake between baseline/placebo scan and glucagon:exenatide scan as measured by 18F-FDG

Difference in global longitudinal strain / global circumferential strain / global radial strain between baseline/placebo CMR and glucagon:exenatide CMR

Difference in ejection fraction between baseline/placebo CMR and glucagon:exenatide CMR

Difference in stroke volume between baseline/placebo CMR and glucagon:exenatide CMR

Difference in cardiac output between baseline/placebo CMR and glucagon:exenatide CMR

Difference in end diastolic volume / end systolic volume between baseline/placebo CMR and glucagon:exenatide CMR

Difference in heart rate between saline/placebo infusion and glucagon:exenatide infusion

Difference in blood pressure between baseline/placebo infusion and glucagon:exenatide infusion

Difference in glucose between saline/placebo infusion and glucagon:exenatide infusion

Difference in glucagon between saline/placebo infusion and glucagon:exenatide infusion

Difference in C-peptide between saline/placebo infusion and glucagon:exenatide infusion

Difference in insulin between saline/placebo infusion and glucagon:exenatide infusion

Difference in fatty acids between saline/placebo infusion and glucagon:exenatide infusion

Difference in exenatide between saline/placebo infusion and glucagon:exenatide infusion

Difference in GLP-1 between saline/placebo infusion and glucagon:exenatide infusion

Difference in gastric inhibitory polypeptide between saline/placebo infusion and glucagon:exenatide infusion

Dr Ian B Wilkinson

Prof Ian Wilkinson

Cambridge University Hospitals NHS Foundation Trust

Antaros Medical AB

Prospective Randomised Open Blinded End-point (PROBE) pilot study

Diagnostic test/procedure - FDG PET/CT
FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan.

Single Group Assignment

Gender

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Change in Maximum Standardized Update Value (SUVmax) in Brown Adipose Tissue FDG Uptake in the Neck or Upper Chest on Evening and Imaging Compared to Morning Imaging

Correlation Between Cortisol Level and Brown Adipose Tissue FDG Uptake

Change in Total Brown Adipose Tissue FDG Uptake as Measured by Total Volume of Segmented Fat Times the Mean Standardized Uptake Value (SUVmean)

Overall Study

Daniel Pryma

Healthy

PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan.

FDG PET/CT

The nuclear receptor Rev-erbα controls circadian thermogenic plasticity.

University of Pennsylvania

Circadian Brown Adipose Tissue Metabolism

A Pilot Study to Investigate Circadian Variations in Brown Adipose Tissue Metabolism in Healthy Volunteers.

Primary Investigator

A total of 12 subjects will receive a single intravenous injection of[18F]FluorbetaOx followed by PET-CT imaging. Four normal healthy volunteer subjects and 8 subjects with or without Type 2 Diabetes Mellitus with Chronic Dilated Cardiomyopathy.

A total of 38 subjects will receive a single intravenous injection of [18F]FluorbetaOx, [11C]Palmitate, and [15O]Water followed by PET-CT imaging. Ten normal healthy volunteer subjects and 28 subjects with or without Type 2 Diabetes Mellitus of which 18 subjects will have Chronic Dilated Cardiomyopathy and 10 obese subjects with a Body Mass Index of ≥ 30kg/m2.

A total of 12 subjects will receive a single intravenous injection of[18F]FluorbetaOx followed by PET-CT imaging. Four normal healthy volunteer subjects and 8 subjects with or without Type 2 Diabetes Mellitus with Chronic Dilated Cardiomyopathy.
[18F]FluorbetaOx: Fluorine 18-labeled FluorbetaOx

Dosimetry Group

A total of 38 subjects will receive a single intravenous injection of [18F]FluorbetaOx, [11C]Palmitate, and [15O]Water followed by PET-CT imaging. Ten normal healthy volunteer subjects and 28 subjects with or without Type 2 Diabetes Mellitus of which 18 subjects will have Chronic Dilated Cardiomyopathy and 10 obese subjects with a Body Mass Index of ≥ 30kg/m2.
[18F]FluorbetaOx: Fluorine 18-labeled FluorbetaOx

Kinetic Dynamic Group

Total

Sex: Female, Male

Race and Ethnicity Not Collected

The values in the table represent the number of participants, specifically Dosimetry and Kinetic patients and that is how the primary endpoint is arrived at. This is how the primary endpoint is determined through PET/CT measurements of Myocardial FA metabolism with F-18 Florbeta Ox.
The data intended for this Outcome Measure use PET/CT images to visualize the amount of myocardial FA metabolism appears with the radio tracer, Florbeta Ox.

The Primary Endpoint is to Determine if PET/CT Measurements of Myocardial FA Metabolism Performed With [18F]FluorbetaOx Correlated With Those Performed With [11C]Palmitate and Calculation of Human Dosimetry.

A total of 0 subjects (Four normal healthy volunteer subjects and0 subjects with or without Type 2 Diabetes Mellitus with Chronic Dilated Cardiomyopathy)will receive a single intravenous injection of 10 mCi of[18F]FluorbetaOx followed by PET-CT imaging at two separate time points.
The difference between primary Outcome and the secondary outcome are the patients themselves. Florbeta Ox was measured in normal healthy volunteers and in non-ischemic cardiomyopathy patients through PET/CT image visualization.

A total of 0 subjects will receive a single intravenous injection of[18F]FluorbetaOx followed by PET-CT imaging. Four normal healthy volunteer subjects and 8 subjects with or without Type 2 Diabetes Mellitus with Chronic Dilated Cardiomyopathy.
[18F]FluorbetaOx: Fluorine 18-labeled FluorbetaOx

A total of 0subjects will receive a single intravenous injection of [18F]FluorbetaOx, [11C]Palmitate, and [15O]Water followed by PET-CT imaging. Ten normal healthy volunteer subjects and 28 subjects with or without Type 2 Diabetes Mellitus of which 18 subjects will have Chronic Dilated Cardiomyopathy and 10 obese subjects with a Body Mass Index of ≥ 30kg/m2.
[18F]FluorbetaOx: Fluorine 18-labeled FluorbetaOx

To Determine Human Dosimetry Based on the Human Biodistribution of [18F](+/-)NOS in Both Normal Healthy Volunteers and Dilated Non-ischemic Cardiomyopathy Patients.

Robert Gropler, MD, Chief of Cardiovascular Imaging Laboratory

Heart Failure

Type 2 Diabetes Mellitus

Health Normal Volunteer Subjects

[18F]FluorbetaOx

Washington University School of Medicine

Fatty Acid Radiotracer Comparison Study in Heart Failure Patients

Measurements of Myocardial Fatty Acid Metabolism With PET and [F-18]FluorbetaOx in Humans With Heart Failure With and Without Diabetes: Comparison With [C-11]Palmitate

fluorine/nutukimas

Effect of Glucagon and Glucagon-like Peptide-1 Co-agonism on Cardiac Function and Metabolism in Overweight Participants With Type 2 Diabetes

Circadian Brown Adipose Tissue Metabolism

Fatty Acid Radiotracer Comparison Study in Heart Failure Patients

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