Diabetes Mellitus, Type 2AM05NCT05132335
A Repeatability Study of Fatty Acid Uptake Using PET/MR Imaging in Patients With T2DM and Non-diabetic Control Subjects
A study testing Imaging Biomarkers in people with Diabetes Mellitus, Type 2, run by Turku University Hospital at 2 sites in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Imaging Biomarkers
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesFinland
- Study dates
- 29 Mar 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Turku PET Centre
Turku, 20520
Turku PET Centre (Turku University Hospital)
Turku, 20521
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Imaging Biomarkers
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging BiomarkersOther
Also called Assessment of repeatability of fatty acid uptake in adipose using PETMRI
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Imaging Biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline through Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start29 Mar 2021
- Primary completion25 Nov 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Antaros Medical
- Responsible party
- Sponsor
- Investigators
- Pirjo R Nuutila, MD, PhD, Principal investigator, Turku PET Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132335
- Sponsor's protocol ID
- AM05
- Acronym
- AM05
- Status last verified
- Aug 2023
- First submitted
- 29 Oct 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: test-retest study, intermediate results not meaningful but the whole data set is reported.
Publications
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.
PubMed 38869780
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05132335
- Acronym / sponsor ID
- AM05 / AM05
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Antaros Medical
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 25 Nov 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Imaging Biomarkers | Experimental | Other: Imaging BiomarkersEach 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. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging BiomarkersAlso: Assessment of repeatability of fatty acid uptake in adipose using PETMRIOne 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 | Other | Experimental: Imaging Biomarkers |
Primary outcome
To evaluate the repeatability of the ratio of subcutaneous adipose tissue (SAT) to skeletal muscle fatty acid uptake rates
Time frame: Baseline through Day 14
The ratio of SAT to skeletal muscle fatty acid uptake rates
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Derived from this study: PubMed 38869780Aarnio 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.
- Individual participant dataSharing planned: No. test-retest study, intermediate results not meaningful but the whole data set is reported.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pirjo R Nuutila, MD, PhD principal investigator
Turku PET Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaging Biomarkers in people with Diabetes Mellitus, Type 2, run by Turku University Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the repeatability of the ratio of subcutaneous adipose tissue (SAT) to skeletal muscle fatty acid uptake rates (time frame: Baseline through Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05132335, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.