A Repeatability Study of Fatty Acid Uptake Using PET/MR Imaging in Patients With T2DM and Non-diabetic Control Subjects (AM05)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Imaging Biomarkers
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- Have a body mass index (BMI) between 25 to 40 kilograms per meter squared (kg/m²),
- For participants with a confirmed type 2 diabetes diagnosis: The condition must be managed either by diet and exercise alone or on a stable dose of metformin
- For nondiabetic subjects: participants must agree to keep their diet and physical activity habits stable throughout the study
- Female participants must be post-menopausal and male participants
Exclusion Criteria:
- Poorly controlled diabetes
- Unstable body weight within 30 days prior to screening.
- For non-diabetic control subjects: evidence of diabetes or prediabetes at screening.
- Having worked as a metal worker or welder
- History of alcohol or drug abuse within 5 years of the screening
- Currently participating, or previous participation in another clinical trial within 30 days prior to the screening visit, or previous participation in another PET imaging study within 12 months.
Sites / Locations
- Turku PET Centre
- Turku PET Centre (Turku University Hospital)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental: Imaging Biomarkers
Arm Description
Each study subject is is studied in four session: twice after overnight fast and twice after liquid meal injestion using PETMRI imaging. Adipose and skeletal muscle pefusion and fatty adic uptake are measured and and the repeability of results tested for these two situations. In PEt studies PET/MRI Scan with radioactive water ([15O]-H2O) and [18F]-FTHA are used as tracers. In this experimental study number of subjects studied is rather small. Therefore volunteers with and without T2 diabetes are analysed together and not on different arms.
Outcomes
Primary Outcome Measures
To evaluate the repeatability of the ratio of subcutaneous adipose tissue (SAT) to skeletal muscle fatty acid uptake rates
The ratio of SAT to skeletal muscle fatty acid uptake rates
Secondary Outcome Measures
Full Information
NCT ID
NCT05132335
First Posted
October 29, 2021
Last Updated
August 9, 2023
Sponsor
Turku University Hospital
Collaborators
Antaros Medical
1. Study Identification
Unique Protocol Identification Number
NCT05132335
Brief Title
A Repeatability Study of Fatty Acid Uptake Using PET/MR Imaging in Patients With T2DM and Non-diabetic Control Subjects
Acronym
AM05
Official Title
Assessment of Fatty Acid Uptake and Blood Flow in Tissues Under Fasting and Postprandial Conditions; a Repeatability Study Using Dynamic PET/MR Imaging in Patients With Type 2 Diabetes and Non-diabetic Control Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
November 25, 2021 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital
Collaborators
Antaros Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The main purpose of this study is to evaluate the overall variation in the assessment of fatty acid uptake and blood flow in adipose tissue and skeletal muscle in the fasted and postprandial states by evaluating the repeatability of whole-body three-dimensional kinetic (4D) combined positron emission tomography and magnetic resonance imaging (PET/MRI) readouts in participants with type 2 diabetes mellitus (T2DM), and non-diabetic control participants. Each volunteer participates 4 scanning sessions.
Detailed Description
A total of approximately 13 T2DM and 6 control subjects (a total of 19 subjects) are planned to be enrolled to achieve 11 T2DM and 5 control subjects to complete the study, assuming a 15% drop-out rate. The test-retest repeatability of the ratio of FTHA uptake rates in subcutaneous adipose tissue (SAT) to skeletal muscle is measured using the intra-class correlation coefficient (ICC). Assuming an ICC of 0.85, with a 5% two-sided type I error rate, a sample size of 16 completers will yield approximately 90% power to detect an ICC statistically significantly greater than 0.4 (usually considered as a criterion for moderate agreement).
The total radiaooin burden for tshi sitdu yis 27.4 mSv. The study is approved by the local Ethical committtee and Fimea.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
One arm: Subjects are studied under two consecutive conditions, after overnight fasting and after a liquid meal ingestion. During each condition they are examined for fatty acid uptake in subcutaneous fat and skeletal muscle by FTHA([18F]-FTHA) PET/MRI as well as adipose and skeletal muscle blood perfusion by radioactive water([15O]-H2O ) PET/MRI. This was done at two occasions, 2-14 days apart, to assess repeatability of the measurements.
Assigned interventions:
[18F]-FTHA tracer injections
[15O]-H2O tracer injections
PET/MRI imaging
Overnight fasting Liquid meal ingestion
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Imaging Biomarkers
Arm Type
Experimental
Arm Description
Each study subject is is studied in four session: twice after overnight fast and twice after liquid meal injestion using PETMRI imaging. Adipose and skeletal muscle pefusion and fatty adic uptake are measured and and the repeability of results tested for these two situations. In PEt studies PET/MRI Scan with radioactive water ([15O]-H2O) and [18F]-FTHA are used as tracers. In this experimental study number of subjects studied is rather small. Therefore volunteers with and without T2 diabetes are analysed together and not on different arms.
Intervention Type
Other
Intervention Name(s)
Imaging Biomarkers
Other Intervention Name(s)
Assessment of repeatability of fatty acid uptake in adipose using PETMRI
Intervention Description
One arm: Subjects are studied under two consecutive conditions, after overnight fasting and after a liquid meal ingestion. During each condition they are examined for fatty acid uptake in subcutaneous fat and skeletal muscle by FTHA([18F]-FTHA) PET/MRI as well as adipose and skeletal muscle blood perfusion by radioactive water([15O]-H2O ) PET/MRI. This was done at two occasions, 2-14 days apart, to assess repeatability of the measurements.
Assigned interventions:
[18F]-FTHA tracer injections [15O]-H2O tracer injections
PET/MRI imaging
Overnight fasting Liquid meal ingestion
Primary Outcome Measure Information:
Title
To evaluate the repeatability of the ratio of subcutaneous adipose tissue (SAT) to skeletal muscle fatty acid uptake rates
Description
The ratio of SAT to skeletal muscle fatty acid uptake rates
Time Frame
Baseline through Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a body mass index (BMI) between 25 to 40 kilograms per meter squared (kg/m²),
For participants with a confirmed type 2 diabetes diagnosis: The condition must be managed either by diet and exercise alone or on a stable dose of metformin
For nondiabetic subjects: participants must agree to keep their diet and physical activity habits stable throughout the study
Female participants must be post-menopausal and male participants
Exclusion Criteria:
Poorly controlled diabetes
Unstable body weight within 30 days prior to screening.
For non-diabetic control subjects: evidence of diabetes or prediabetes at screening.
Having worked as a metal worker or welder
History of alcohol or drug abuse within 5 years of the screening
Currently participating, or previous participation in another clinical trial within 30 days prior to the screening visit, or previous participation in another PET imaging study within 12 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pirjo R Nuutila, MD, PhD
Organizational Affiliation
Turku PET Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turku PET Centre
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Turku PET Centre (Turku University Hospital)
City
Turku
ZIP/Postal Code
20521
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
test-retest study, intermediate results not meaningful but the whole data set is reported.
Learn more about this trial
A Repeatability Study of Fatty Acid Uptake Using PET/MR Imaging in Patients With T2DM and Non-diabetic Control Subjects
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