NCT02025595

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 1, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

2.8 years

First QC Date

December 13, 2013

Last Update Submit

May 9, 2017

Conditions

Keywords

BrainGenesEnvironmentEtiologyRewardSatiety ResponseCentral Nervous SystemMagnetic Resonance ImagingTwins, MonozygoticOverweightObesity

Outcome Measures

Primary Outcomes (3)

  • 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.

    Baseline (one measurement)

  • 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.

    Baseline (one measurement)

  • 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.

    Baseline (one measurement)

Secondary Outcomes (10)

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

    Baseline (one measurement)

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

    Baseline (one measurement)

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

    Baseline (one measurement)

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

    Baseline (one measurement)

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

    Baseline (one measurement)

  • +5 more secondary outcomes

Other Outcomes (4)

  • The difference within obesity-discordant monozygotic (MZ) twin pairs regarding gut microbiota composition

    Baseline (one measurement)

  • The difference within obesity-discordant monozygotic (MZ) twin pairs regarding epigenetic changes

    Baseline (one measurement)

  • The difference between individuals at high versus those at low genetic obesity risk regarding gut microbiota composition

    Baseline (one measurement)

  • +1 more other outcomes

Study Arms (2)

Monozygotic twin pairs

15 monozygotic twin pairs discordant for obesity

Genetic predisposition for obesity

15 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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VU University Medical Center

Amsterdam, 1081HV, Netherlands

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD FRCPE, Professor of Internal Medicine, Chair of Diabetology, Director of Diabetes Center VUmc

Study Record Dates

First Submitted

December 13, 2013

First Posted

January 1, 2014

Study Start

December 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

May 10, 2017

Record last verified: 2017-05

Locations