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OpenTrials
Completed

NCT Number: NCT02025595

Obesity and Brain: Genes and Environment

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

VU University Medical Center

Amsterdam, 1081HV, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline (one measurement)

Secondary outcomes

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

    Time frame: Baseline (one measurement)

    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.

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

    Time frame: Baseline (one measurement)

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

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

    Time frame: Baseline (one measurement)

    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.

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

    Time frame: Baseline (one measurement)

    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.

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

    Time frame: Baseline (one measurement)

    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.

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

    Time frame: Baseline (one measurement)

    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.

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

    Time frame: Baseline (one measurement)

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

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

    Time frame: Baseline (one measurement)

    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.

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

    Time frame: Baseline (one measurement)

    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.

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

    Time frame: Baseline (one measurement)

    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.

Other outcomes

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

    Time frame: Baseline (one measurement)

    Gut microbiota composition (ratio between various gut microbiota species) will be assessed by identifying microbial phylotypes in a feces sample using 16S ribosomal RNA molecule-based approaches of diagnostic analysis. Function of gut microbiota will be investigated using metaproteomics analysis techniques that include mass-spectroscopy methodologies.

    Please note: this outcome measure is conditional to available budget.

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

    Time frame: Baseline (one measurement)

    Epigenetic changes will be assessed by measuring global DNA methylation (%) and locus specific DNA methylation (%) in regions of selected loci using a mass spectrometry-based method. Loci will be selected on the basis of their previously shown features of epigenetic regulation and their involvement in cardiovascular and metabolic disease.

    Please note: this outcome measure is conditional to available budget.

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

    Time frame: Baseline (one measurement)

    Gut microbiota composition (ratio between various gut microbiota species) will be assessed by identifying microbial phylotypes in a feces sample using 16S ribosomal RNA molecule-based approaches of diagnostic analysis. Function of gut microbiota will be investigated using metaproteomics analysis techniques that include mass-spectroscopy methodologies.

    Please note: this outcome measure is conditional to available budget.

  4. The difference between individuals at high versus those at low genetic obesity risk regarding epigenetic changes

    Time frame: Baseline (one measurement)

    Epigenetic changes will be assessed by measuring global DNA methylation (%) and locus specific DNA methylation (%) in regions of selected loci using a mass spectrometry-based method. Loci will be selected on the basis of their previously shown features of epigenetic regulation and their involvement in cardiovascular and metabolic disease.

    Please note: this outcome measure is conditional to available budget.

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 1, 2014
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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