Clinical trial NCT02025595: Obesity and Brain: Genes and Environment
Official title: The Role of Central Reward and Satiety Centers in the Etiology of Obesity: Genetic and Environmental Influences
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Brain
Genes
Environment
Etiology
Reward
Satiety Response
Central Nervous System
Magnetic Resonance Imaging
Twins, Monozygotic
Overweight
Obesity
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the Netherlands Twin Registry (NTR). All subjects are voluntary participants and have received surveys on lifestyle and health every 2 years. In addition, genome wide data are available in a large number of these individuals.

Brief summary: The aim of this study is to investigate the effects of genetic and environmental risk factors on central nervous system (CNS) reward and satiety circuits in the etiology of obesity. The investigators will also investigate to what extent the alterations in CNS reward and satiety circuits are a cause or a consequence of the development of obesity.


Eligibility criteria: Inclusion Criteria:

* Age 18-75 years
* Male or female
* Stable bodyweight (\<5% reported weight change during previous 3 months)
* Women: regular menstruation cycle (to exclude possible menstruation cycle effects)
* Normal fasting blood glucose

Exclusion Criteria:

* Left handedness
* Known diabetes or abnormal fasting blood glucose
* Serious heart, pulmonary, hepatic or renal disease, malignant or hematological disease
* Metabolic disorders (uncontrolled adrenal/thyroid disease)
* Women: irregular menstruation cycle
* Neurological or psychiatric illness
* Pregnancy or breast feeding
* Alcohol abuse
* Nicotine abuse
* Claustrophobia or metal implants
* Visual disability
* Participation in another study
* Inability to understand the protocol or to give informed consent
* Current/chronic use of following medication: antihyperglycemic agents, glucocorticoids, centrally acting drugs, cytostatics, immune suppressants, potentially addictive medications.

Primary outcomes:
measure: The difference in neuronal activity in CNS reward and satiety circuits as represented by BOLD functional magnetic resonance imaging (fMRI) signal change from baseline (%) in response to food-related stimuli within obesity discordant MZ twin pairs.
timeFrame: Baseline (one measurement)
measure: The difference in neuronal activity in CNS reward and satiety circuits as represented by BOLD fMRI signal change from baseline (%) in response to food-related stimuli between individuals at high verses low genetic obesity risk.
timeFrame: Baseline (one measurement)
measure: The difference in neuronal activity in CNS reward and satiety circuits as represented by BOLD fMRI signal change from baseline (%) in response to food-related stimuli between lean and obese subjects with either high or low genetic obesity risk.
timeFrame: Baseline (one measurement)
Secondary outcomes:
measure: The difference within obesity-discordant monozygotic (MZ) twin pairs regarding dietary intake
timeFrame: Baseline (one measurement)
measure: The difference within obesity-discordant monozygotic (MZ) twin pairs regarding physical activity level
timeFrame: Baseline (one measurement)
measure: The difference within obesity-discordant monozygotic (MZ) twin pairs regarding basal metabolic rate
timeFrame: Baseline (one measurement)
measure: The difference within obesity-discordant monozygotic (MZ) twin pairs regarding fasting circulating biomarker levels
timeFrame: Baseline (one measurement)
measure: The difference within obesity-discordant monozygotic (MZ) twin pairs regarding autonomic nervous system balance
timeFrame: Baseline (one measurement)
measure: The difference between individuals at high versus those at low genetic obesity risk regarding dietary intake
timeFrame: Baseline (one measurement)
measure: The difference between individuals at high versus those at low genetic obesity risk regarding physical activity level
timeFrame: Baseline (one measurement)
measure: The difference between individuals at high versus those at low genetic obesity risk regarding basal metabolic rate
timeFrame: Baseline (one measurement)
measure: The difference between individuals at high versus those at low genetic obesity risk regarding fasting circulating biomarker levels
timeFrame: Baseline (one measurement)
measure: The difference between individuals at high versus those at low genetic obesity risk regarding autonomic nervous system balance
timeFrame: Baseline (one measurement)
Other outcomes:
measure: The difference within obesity-discordant monozygotic (MZ) twin pairs regarding gut microbiota composition
timeFrame: Baseline (one measurement)
measure: The difference within obesity-discordant monozygotic (MZ) twin pairs regarding epigenetic changes
timeFrame: Baseline (one measurement)
measure: The difference between individuals at high versus those at low genetic obesity risk regarding gut microbiota composition
timeFrame: Baseline (one measurement)
measure: The difference between individuals at high versus those at low genetic obesity risk regarding epigenetic changes
timeFrame: Baseline (one measurement)
Locations:
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
Study officials:
References:
citation: Doornweerd S, De Geus EJ, Barkhof F, Van Bloemendaal L, Boomsma DI, Van Dongen J, Drent ML, Willemsen G, Veltman DJ, IJzerman RG. Brain reward responses to food stimuli among female monozygotic twins discordant for BMI. Brain Imaging Behav. 2018 Jun;12(3):718-727. doi: 10.1007/s11682-017-9711-1.
citation: Doornweerd S, IJzerman RG, van der Eijk L, Neter JE, van Dongen J, van der Ploeg HP, de Geus EJ. Physical activity and dietary intake in BMI discordant identical twins. Obesity (Silver Spring). 2016 Jun;24(6):1349-55. doi: 10.1002/oby.21475. Epub 2016 Apr 23.