A Repeatability Study of Fatty Acid Uptake Using PET/MR Imaging in Patients With T2DM and Non-diabetic Control Subjects

NCT05132335 | Completed

• 1 other identifier: AM05
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline through Day 14

Study Arms (1)

Experimental: Imaging Biomarkers

EXPERIMENTAL

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.

Other: Imaging Biomarkers

Interventions

Imaging Biomarkers OTHER

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

Also known as: Assessment of repeatability of fatty acid uptake in adipose using PETMRI

Experimental: Imaging Biomarkers

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Turku University Hospital: lead
• Antaros Medical: collaborator

Study Sites (2)

Turku PET Centre

Turku, 20520, Finland

Location

Turku PET Centre (Turku University Hospital)

Turku, 20521, Finland

Location

Related Publications (1)

• Aarnio R, Kirjavainen A, Rajander J, Forsback S, Kalliokoski K, Nuutila P, Milicevic Z, Coskun T, Haupt A, Laitinen I, Haaparanta-Solin M. New improved radiometabolite analysis method for [18F]FTHA from human plasma: a test-retest study with postprandial and fasting state. EJNMMI Res. 2024 Jun 13;14(1):53. doi: 10.1186/s13550-024-01114-5.

  PMID: 38869780 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Pirjo R Nuutila, MD, PhD

  Turku PET Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 24, 2021
• Study Start: March 29, 2021
• Primary Completion: November 25, 2021
• Study Completion: April 30, 2022
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)