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Diabetes Mellitus, Type 2CMgeneNCT03310502

Variation of Genes Controlling Carbohydrate and Lipid Metabolism

An observational study of Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Turku University Hospital at 1 site in Finland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Aim of the study is to investigate genes regulating glucose and lipid metabolism in subjects whose glucose metabolism, lipid metabolism, blood flow, or body fat distribution has been measured using positron emission tomography (PET), magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRS) or computed… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
2,050 participants
Where
1 siteFinland
Study dates
17 Apr 2002to 31 Dec 2024
Phase
Observational
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Study population consists of participants of previous studies measuring glucose metabolism, lipid metabolism, bloow flow and adiposity at Turku PET Centre. Important subgroups in this study population are healthy volunteers, participants with obesity, prediabetes, type 2 diabetes or cardiovascular disease.

Who may be able to join

  • Previous participation of studies measuring glucose metabolism, lipid metabolism, bloow flow and adiposity at Turku PET Centre

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Pirjo R Nuutila, MD, PhD contact

+35823131868

pirnuu@utu.fi

Miikka Honka, MSc contact

+35823132798

mjhonk@utu.fi

Finland1 site, 1 recruiting

  • Turku PET Centre (Turku University Hospital)

    Turku, 20521

    Pirjo Nuutila, M.D., Ph.D., +358 2 2611 868, pirnuu@utu.fi

    Recruiting

Other trials in Finland

About this study

Aim of the study is to investigate genes regulating glucose and lipid metabolism in subjects whose glucose metabolism, lipid metabolism, blood flow, or body fat distribution has been measured using positron emission tomography (PET), magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRS) or computed tomography (CT) as part of their previous participation in clinical trials conducted at Turku PET Centre.

By combining information from PET, MRI, CT, proteomics, metabolomics and genetics analyses we aim to find connection between genetic variation and metabolic and cardiovascular disease.

Read the detailed description

The data is collected as a separate part of the clinical imaging study protocols using a separate inform consent approved by the local ethics committee. The participation for this study consists of drawing whole blood, serum and plasma samples for genetics, proteomics and metabolomics analyses. The results from these studies are combined with baseline data from the original clinical imaging studies to find connections between genetic variation, metabolism, blood flow and body fat distribution in a cross-sectional setting.

Keywords
positron emission tomography, skeletal muscle, liver, adipose tissue, brain, genetics
Medical subject headings
Diabetes Mellitus, Type 2, Cardiovascular Diseases, Obesity, Insulin Resistance, Lipid Metabolism Disorders, Prediabetic State

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Skeletal muscle insulin sensitivity

    Skeletal muscle glucose uptake during euglycemic-hyperinsulinemic clamp (µmol/kg tissue/min)

    Measured: Baseline

Secondary outcomes (21)

  1. Whole body insulin sensitivity

    Whole body glucose uptake during euglycemic-hyperinsulinemic clamp (µmol/kg body weight/min)

    Measured: Baseline

  2. Visceral adipose tissue insulin sensitivity to glucose uptake

    Visceral adipose tissue glucose uptake during euglycemic-hyperinsulinemic clamp (µmol/kg tissue/min)

    Measured: Baseline

  3. Abdominal subcutaneous adipose tissue insulin sensitivity to glucose uptake

    Abdominal subcutaneous adipose tissue glucose uptake during euglycemic-hyperinsulinemic clamp (µmol/kg tissue/min)

    Measured: Baseline

  4. Brown adipose tissue insulin sensitivity

    Brown adipose tissue glucose uptake during euglycemic-hyperinsulinemic clamp (µmol/kg tissue/min)

    Measured: Baseline

  5. Brown adipose tissue glucose uptake during cold exposure

    Brown adipose tissue glucose uptake during cold exposure (µmol/kg tissue/min)

    Measured: Baseline

  6. Insulin sensitivity of adipose tissue lipolysis

    Plasma free fatty acid concentration during euglycemic-hyperinsulinemic clamp (mmol/l)

    Measured: Baseline

  7. Myocardial insulin sensitivity

    Myocardial glucose uptake during euglycemic-hyperinsulinemic clamp (µmol/kg tissue/min)

    Measured: Baseline

  8. Liver insulin sensitivity to glucose uptake

    Liver glucose uptake during euglycemic-hyperinsulinemic clamp (µmol/kg tissue/min)

    Measured: Baseline

  9. Endogenous glucose production

    Endogenous glucose production during euglycemic-hyperinsulinemic clamp (µmol/kg body weight/min)

    Measured: Baseline

  10. Brain insulin sensitivity to glucose uptake

    Brain glucose uptake during euglycemic-hyperinsulinemic clamp (µmol/kg tissue/min)

    Measured: Baseline

  11. Abdominal subcutaneous adipose tissue mass

    Abdominal subcutaneous adipose tissue mass (kg)

    Measured: Baseline

  12. Visceral adipose tissue mass

    Visceral adipose tissue mass (kg)

    Measured: Baseline

  13. Liver fat content

    Liver fat percentage (%)

    Measured: Baseline

  14. Myocardial fatty acid uptake

    Myocardial fatty acid uptake at fasting state (µmol/kg tissue/min)

    Measured: Baseline

  15. Liver fatty acid uptake

    Liver fatty acid uptake at fasting state (µmol/kg tissue/min)

    Measured: Baseline

  16. Abdominal subcutaneous adipose tissue fatty acid uptake

    Abdominal subcutaneous adipose tissue fatty acid uptake at fasting state (µmol/kg tissue/min)

    Measured: Baseline

  17. Visceral adipose tissue fatty acid uptake

    Visceral adipose tissue fatty acid uptake at fasting state (µmol/kg tissue/min)

    Measured: Baseline

  18. Brown adipose tissue fatty acid uptake at fasting state

    Brown adipose tissue fatty acid uptake at fasting state (µmol/kg tissue/min)

    Measured: Baseline

  19. Brown adipose tissue fatty acid uptake during cold exposure

    Brown adipose tissue fatty acid uptake at cold exposure (µmol/kg tissue/min)

    Measured: Baseline

  20. Skeletal muscle fatty acid uptake

    Skeletal muscle fatty acid uptake at fasting state (µmol/kg tissue/min)

    Measured: Baseline

  21. Coronary flow reserve

    Ratio of myocardial blood flow maximum at stress (ml/g/min) vs. myocardial blood flow at rest (ml/g/min)

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2017
  2. Study start17 Apr 2002
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
2,050 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03310502
Sponsor's protocol ID
CMgene
Acronym
CMgene
Status last verified
Oct 2021
First submitted
21 Sep 2017
Last updated
13 Oct 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Sharing individual participant data is currently forbidden according to Finnish law.

Publications

  • Tuomola N, Rebelos E, Latva-Rasku A, Bucci M, Immonen H, Saunavaara V, Laine S, Sjoros T, Garthwaite T, Raiko JRH, Fernandes Silva L, Virtanen KA, Hannukainen JC, Ala-Korpela M, Kalliokoski KK, Heinonen IHA, Nuutila P, Honka MJ. Mildly elevated liver lipid content is characterised by reduced insulin sensitivity. JHEP Rep. 2025 Aug 6;7(11):101535. doi: 10.1016/j.jhepr.2025.101535. eCollection 2025 Nov.

    PubMed 41113123

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Turku University Hospital at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pirjo R Nuutila, MD, PhD (+35823131868, pirnuu@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Skeletal muscle insulin sensitivity (time frame: Baseline). 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 NCT03310502, 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 13 Oct 2021.

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