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ObesityNCT02025595

Obesity and Brain: Genes and Environment

An observational study of Obesity, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
How many people
92 participants
Where
1 siteNetherlands
Study dates
Dec 2013to Sep 2016
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 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • VU University Medical Center

    Amsterdam, 1081HV

Other trials in Netherlands

About this study

Official title: The Role of Central Reward and Satiety Centers in the Etiology of Obesity: Genetic and Environmental Influences

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.

Conditions
Obesity
Keywords
Brain, Genes, Environment, Etiology, Reward, Satiety Response, Central Nervous System, Magnetic Resonance Imaging, Twins, Monozygotic, Overweight, Obesity
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02025595
Study groupRoleWhat they receive
Monozygotic twin pairs15 monozygotic twin pairs discordant for obesity
Genetic predisposition for obesity15 obese and 15 non-obese individuals with a high genotype obesity risk score and 15 obese and 15 non-obese individuals with a low genotype obesity risk score. Genotype obesity risk score will be based on genome wide association single-nucleotide polymorphisms (SNP's) associated with obesity.

What is being measured

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

  1. 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.

    Measured: Baseline (one measurement)

  2. 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.

    Measured: Baseline (one measurement)

  3. 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.

    Measured: Baseline (one measurement)

Secondary outcomes (10)

  1. The difference within obesity-discordant monozygotic (MZ) twin pairs regarding dietary intake

    Dietary intake will be measured as quantitative (kcal/day) and qualitative (energy density (kcal/kg) and macronutrient composition (%)) dietary intake using A) a choice lunch buffet on the visit day and B) the 24 hours recall method on two week days and one weekend day at home.

    Measured: Baseline (one measurement)

  2. The difference within obesity-discordant monozygotic (MZ) twin pairs regarding physical activity level

    Physical activity level will be measured as metabolic equivalent of task (METs)-hours per week using seven-day ActiGraph triaxial accelerometry at home.

    Measured: Baseline (one measurement)

  3. The difference within obesity-discordant monozygotic (MZ) twin pairs regarding basal metabolic rate

    Basal metabolic rate will be measured in kcal/day using oxygen consumption and carbon dioxide production measured by indirect calorimetry using a ventilated hood system.

    Measured: Baseline (one measurement)

  4. The difference within obesity-discordant monozygotic (MZ) twin pairs regarding fasting circulating biomarker levels

    Fasting circulating biomarker levels (glucose (mmol/l), HbA1c (mmol/mol), insulin (pmol/l), C-peptide (nmol/l), glucagon (pmol/l), triglycerides (mmol/l), HDL-cholesterol (mmol/l) and LDL-cholesterol (mmol/l)) will be measured in a fasting blood sample.

    Measured: Baseline (one measurement)

  5. The difference within obesity-discordant monozygotic (MZ) twin pairs regarding autonomic nervous system balance

    Autonomic nervous system balance will be assessment based on measurements of A) heart rate variability (HRV; calculated as root mean square of successive R-R interval differences (RMSSD) in ms2); B) respiratory rate (RR; breaths/min) and C) respiratory sinus arrhythmia (RSA; ms) in resting conditions and in response to a mental arithmetic task using an electro- and impedance cardiogram.

    Measured: Baseline (one measurement)

  6. The difference between individuals at high versus those at low genetic obesity risk regarding dietary intake

    Dietary intake will be measured as quantitative (kcal/day) and qualitative (energy density (kcal/kg) and macronutrient composition (%)) dietary intake using A) a choice lunch buffet on the visit day and B) the 24 hours recall method on two week days and one weekend day at home.

    Measured: Baseline (one measurement)

  7. The difference between individuals at high versus those at low genetic obesity risk regarding physical activity level

    Physical activity level will be measured as metabolic equivalent of task (METs)-hours per week using seven-day ActiGraph triaxial accelerometry at home.

    Measured: Baseline (one measurement)

  8. The difference between individuals at high versus those at low genetic obesity risk regarding basal metabolic rate

    Basal metabolic rate will be measured in kcal/day using oxygen consumption and carbon dioxide production measured by indirect calorimetry using a ventilated hood system.

    Measured: Baseline (one measurement)

  9. The difference between individuals at high versus those at low genetic obesity risk regarding fasting circulating biomarker levels

    Fasting circulating biomarker levels (glucose (mmol/l), HbA1c (mmol/mol), insulin (pmol/l), C-peptide (nmol/l), glucagon (pmol/l), triglycerides (mmol/l), HDL-cholesterol (mmol/l) and LDL-cholesterol (mmol/l)) will be measured in a fasting blood sample.

    Measured: Baseline (one measurement)

  10. The difference between individuals at high versus those at low genetic obesity risk regarding autonomic nervous system balance

    Autonomic nervous system balance will be assessment based on measurements of A) heart rate variability (HRV; calculated as root mean square of successive R-R interval differences (RMSSD) in ms2); B) respiratory rate (RR; breaths/min) and C) respiratory sinus arrhythmia (RSA; ms) in resting conditions and in response to a mental arithmetic task using an electro- and impedance cardiogram.

    Measured: Baseline (one measurement)

Timeline

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

  1. First posted1 Jan 2014 (estimated)
  2. Study startDec 2013
  3. Primary completionSep 2016
  4. Study completionSep 2016

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
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02025595
Sponsor's protocol ID
DC2013ObesiBrain001
Other IDs
NL 44735.029.13, 91613082
Status last verified
May 2017
First submitted
13 Dec 2013
Last updated
10 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 28597337

  • 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.

    PubMed 27106364

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

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 5 inclusion and 14 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 10 May 2017. 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 Netherlands. 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?

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. (time frame: Baseline (one measurement)). The study lists 3 primary outcomes in all. 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 NCT02025595, which also lists 2 linked publications.

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 10 May 2017.

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