Neuromolecular Risk Factors for Obesity (PROSPECT)
Detecting Neuromolecular Risk Factors for Obesity
1 other identifier
interventional
60
1 country
1
Brief Summary
The goal of this project is to characterize the neural and psychological mechanisms that contribute to development of obesity in the early adulthood. We address the neuromolecular risk factors for obesity using multi-modal molecular (positron emission tomography with) and functional (functional magnetic resonance imaging) neuroimaging in a prospective design. Normal weight adolescents with high versus low familial, genetic and psychological risk factors for obesity will be studied and followed for five years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Apr 2017
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2017
CompletedStudy Start
First participant enrolled
April 4, 2017
CompletedFirst Posted
Study publicly available on registry
April 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedDecember 17, 2021
December 1, 2021
5.7 years
March 5, 2017
December 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neuromolecular risk score for weight gain
Acquired with combining the measured BMI change in five years to measured alterations in brain function (see below).
Within five study years
Secondary Outcomes (12)
Localization of on-going neural activity during various cognitive and affective tasks
Within one study day
Brain and body glucose uptake
Within one study day
Brain and body CB1 availability
Within one study day
Brain MOR availability
Within one study day
Genes regulating MOR (OPRM1) and D2R (DRD2) expression
Within one study week
- +7 more secondary outcomes
Study Arms (2)
Low-risk group
ACTIVE COMPARATORIndividuals in the low-risk group are not in a risk of developing obesity according to traditional risk criteria.
High-risk group
ACTIVE COMPARATORIndividuals in the high-risk group are in a risk of developing obesity according to traditional risk criteria.
Interventions
Using blood oxygenation level dependent (BOLD) echo-planar imaging, fMRI will be used for characterising individual differences in the brain circuits.
\[11C\]carfentanil is used to measure μ-opioid receptor (MOR) availability in brain.
\[18F\]FMPEP-d2 is used to measure cannabinoid receptor type 1 (CB1) availability in brain and body.
Brain and body insuin stimulated glucose uptake is measured with radioligand \[18F\]-FDG.
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.
Weight, height, blood pressure, medical history, and current medication are determined. Body fat percentage will be assessed using BodPod plethysmograph.
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.
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
You may qualify if:
- Male sex
- 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
You may not qualify if:
- Any chronic disease or medication that could affect glucose metabolism or neurotransmission
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Turku PET Centre (Turku University Hospital)
Turku, 20521, Finland
Related Publications (1)
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.
PMID: 15919837BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pirjo Nuutila, M.D., Ph.D.
Turku PET Centre (Turku University Hospital)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 5, 2017
First Posted
April 10, 2017
Study Start
April 4, 2017
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
December 17, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share