Clinical trial NCT05132335: A Repeatability Study of Fatty Acid Uptake Using PET/MR Imaging in Patients With T2DM and Non-diabetic Control Subjects
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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Antaros Medical
First posted: 2021-11-24
Enrollment: 19
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: To evaluate the repeatability of the ratio of subcutaneous adipose tissue (SAT) to skeletal muscle fatty acid uptake rates
timeFrame: Baseline through Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku PET Centre
city: Turku
country: Finland
facility: Turku PET Centre (Turku University Hospital)
Study officials:
affiliation: Turku PET Centre
name: Pirjo R Nuutila, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: