Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2017-04-04
2022-12-01
Brief Summary
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Detailed Description
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A total of sixty males (30 normal-weight, 30 with risk for developing obesity) are recruited into this prospective study. The subjects will undergo physical examination, physical fitness tests, physical activity measures, body tissue composition measurement, structural and functional magnetic resonance imaging of the brain and body (MRI \& fMRI), and positron emission tomography (PET) with ligands \[18F\]-fluorodeoxyglucose (\[18F\]-FDG), \[18-F\]FMPEP, and \[11C\]carfentanil. Subjects' weight and physical condition will be followed up for 5 years.
In three interconnected work packages (WPs) we test three hypotheses derived from human and animal studies:
1. Altered reward and cognitive control functions in the brain predisposes some individuals to overeating and obesity.
2. Opioid system and reward circuit function provide feasible biomarkers for obesity risk.
3. Mobile tracking and behavioural paradigms tapping reward learning and inhibitory control can be used for unobtrusive and inexpensive detection of risk factors for obesity.
These studies will improve our understanding of the neural and psychological mechanisms of obesity and addictive disorders. This knowledge will translate into crucial knowledge for developing novel risk factor screening procedures, and novel pharmacological and psychological treatments for obesity.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
FACTORIAL
BASIC_SCIENCE
NONE
Study Groups
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Low-risk group
Individuals in the low-risk group are not in a risk of developing obesity according to traditional risk criteria.
fMRI imaging
Using blood oxygenation level dependent (BOLD) echo-planar imaging, fMRI will be used for characterising individual differences in the brain circuits.
[11C]carfentanil PET scan
\[11C\]carfentanil is used to measure μ-opioid receptor (MOR) availability in brain.
[18F]FMPEP-d2 PET scan
\[18F\]FMPEP-d2 is used to measure cannabinoid receptor type 1 (CB1) availability in brain and body.
[18F]-FDG PET scan
Brain and body insuin stimulated glucose uptake is measured with radioligand \[18F\]-FDG.
Physical activity measures and fitness tests
Physical activity will be measured over one week following the screening check-up, before the PET measurement days. For the measurement, subjects will wear Polar M600 GPS Sports Watch for the measurement period. The fitness tests will be performed at the Paavo Nurmi Centre.
Laboratory measurements
Weight, height, blood pressure, medical history, and current medication are determined. Body fat percentage will be assessed using BodPod plethysmograph.
Questionnaires
All the participants will complete a self-administered questionnaire at baseline, and at 12 months, for assessment of leisure-time physical activity (LTPA). The following questionnaires will be completed: Behavioural inhibition / activation, Dutch Eating Behaviour Questionnaire, Yale Food Addiction Scale, PCL-Revised, Food craving State / Trait (FCS-FCST) questionnaires, Autism Spectrum Quotient, State-Trait Anxiety Questionnaire and Pain Sensitivity Questionnaire.
Hyperinsulinemic euglycemic clamp
Low-dose hyperinsulinemic euglycemic clamp technique will be used to promote glucose uptake and measure insulin sensitivity of the subjects. In the clamp study subjects are administered intravenous insulin at a steady rate of 0.25 mU/kg/min and normoglycemia is maintained using a variable rate infusion of 20 % glucose based on plasma glucose measurements, which are performed every 5-10 min from arterialized venous blood.
High-risk group
Individuals in the high-risk group are in a risk of developing obesity according to traditional risk criteria.
fMRI imaging
Using blood oxygenation level dependent (BOLD) echo-planar imaging, fMRI will be used for characterising individual differences in the brain circuits.
[11C]carfentanil PET scan
\[11C\]carfentanil is used to measure μ-opioid receptor (MOR) availability in brain.
[18F]FMPEP-d2 PET scan
\[18F\]FMPEP-d2 is used to measure cannabinoid receptor type 1 (CB1) availability in brain and body.
[18F]-FDG PET scan
Brain and body insuin stimulated glucose uptake is measured with radioligand \[18F\]-FDG.
Physical activity measures and fitness tests
Physical activity will be measured over one week following the screening check-up, before the PET measurement days. For the measurement, subjects will wear Polar M600 GPS Sports Watch for the measurement period. The fitness tests will be performed at the Paavo Nurmi Centre.
Laboratory measurements
Weight, height, blood pressure, medical history, and current medication are determined. Body fat percentage will be assessed using BodPod plethysmograph.
Questionnaires
All the participants will complete a self-administered questionnaire at baseline, and at 12 months, for assessment of leisure-time physical activity (LTPA). The following questionnaires will be completed: Behavioural inhibition / activation, Dutch Eating Behaviour Questionnaire, Yale Food Addiction Scale, PCL-Revised, Food craving State / Trait (FCS-FCST) questionnaires, Autism Spectrum Quotient, State-Trait Anxiety Questionnaire and Pain Sensitivity Questionnaire.
Hyperinsulinemic euglycemic clamp
Low-dose hyperinsulinemic euglycemic clamp technique will be used to promote glucose uptake and measure insulin sensitivity of the subjects. In the clamp study subjects are administered intravenous insulin at a steady rate of 0.25 mU/kg/min and normoglycemia is maintained using a variable rate infusion of 20 % glucose based on plasma glucose measurements, which are performed every 5-10 min from arterialized venous blood.
Interventions
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fMRI imaging
Using blood oxygenation level dependent (BOLD) echo-planar imaging, fMRI will be used for characterising individual differences in the brain circuits.
[11C]carfentanil PET scan
\[11C\]carfentanil is used to measure μ-opioid receptor (MOR) availability in brain.
[18F]FMPEP-d2 PET scan
\[18F\]FMPEP-d2 is used to measure cannabinoid receptor type 1 (CB1) availability in brain and body.
[18F]-FDG PET scan
Brain and body insuin stimulated glucose uptake is measured with radioligand \[18F\]-FDG.
Physical activity measures and fitness tests
Physical activity will be measured over one week following the screening check-up, before the PET measurement days. For the measurement, subjects will wear Polar M600 GPS Sports Watch for the measurement period. The fitness tests will be performed at the Paavo Nurmi Centre.
Laboratory measurements
Weight, height, blood pressure, medical history, and current medication are determined. Body fat percentage will be assessed using BodPod plethysmograph.
Questionnaires
All the participants will complete a self-administered questionnaire at baseline, and at 12 months, for assessment of leisure-time physical activity (LTPA). The following questionnaires will be completed: Behavioural inhibition / activation, Dutch Eating Behaviour Questionnaire, Yale Food Addiction Scale, PCL-Revised, Food craving State / Trait (FCS-FCST) questionnaires, Autism Spectrum Quotient, State-Trait Anxiety Questionnaire and Pain Sensitivity Questionnaire.
Hyperinsulinemic euglycemic clamp
Low-dose hyperinsulinemic euglycemic clamp technique will be used to promote glucose uptake and measure insulin sensitivity of the subjects. In the clamp study subjects are administered intravenous insulin at a steady rate of 0.25 mU/kg/min and normoglycemia is maintained using a variable rate infusion of 20 % glucose based on plasma glucose measurements, which are performed every 5-10 min from arterialized venous blood.
Eligibility Criteria
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Inclusion Criteria
* Age 20-35 years
* BMI 20-24 kg/m2
* Physical exercise \> 4 hrs per week
* No maternal / paternal obesity OR maternal / paternal type 2 diabetes mellitus (T2DM)
* Male sex
* Age 20-35 years
* BMI 25 - 30 kg/m2
* Maternal / paternal obesity OR maternal / paternal T2DM
* Physical exercise \< 4 hrs per week
Exclusion Criteria
* History of anorexia nervosa, bulimia or other eating disorder (excl. common obesity)
* Smoking of tobacco, taking of snuffs, or use of narcotics
* Abusive use of alcohol
* Any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
20 Years
35 Years
MALE
Yes
Sponsors
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Turku University Hospital
OTHER_GOV
Responsible Party
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Pirjo Nuutila
Professor
Principal Investigators
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Pirjo Nuutila, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Turku PET Centre (Turku University Hospital)
Locations
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Turku PET Centre (Turku University Hospital)
Turku, , Finland
Countries
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References
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Frisard MI, Greenway FL, Delany JP. Comparison of methods to assess body composition changes during a period of weight loss. Obes Res. 2005 May;13(5):845-54. doi: 10.1038/oby.2005.97.
Other Identifiers
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PROSPECT
Identifier Type: -
Identifier Source: org_study_id