Trial Outcomes & Findings for Brain Dopamine Function in Human Obesity (NCT NCT03648892)
NCT ID: NCT03648892
Last Updated: 2023-07-11
Results Overview
Correlations between striatal D2BP via \[18F\]Fallypride and striatal D2BP via \[11C\]Raclopride is obtained. Pearson's correlation coefficient is used with a possible range between -1 to 1 indicating strong association in the same direction as correlation is closer to 1, strong association in opposite direction as correlation is closer to -1, and no association as correlation is closer to 0.
COMPLETED
EARLY_PHASE1
61 participants
assessed at Days 2-5
2023-07-11
Participant Flow
Participant milestones
| Measure |
Dopamine D2/3 Receptor Antagonists
Healthy volunteers, within three Body Mass Index (BMI) strata, under controlled overnight fasting conditions following a period of dietary stabilization. The present study will attempt to resolve the controversy surrounding the relationship between BMI and dopamine D2 receptor availability by measuring D2 Receptor Binding Potential (D2BP) using both \[18F\]Fallypride and \[11C\]Raclopride in pseudorandom order during days 2-5 of the inpatient stay.
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Overall Study
STARTED
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61
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Overall Study
COMPLETED
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61
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brain Dopamine Function in Human Obesity
Baseline characteristics by cohort
| Measure |
Dopamine D2/3 Receptor Antagonists
n=61 Participants
Healthy volunteers, within three Body Mass Index (BMI) strata, under controlled overnight fasting conditions following a period of dietary stabilization. The present study will attempt to resolve the controversy surrounding the relationship between BMI and dopamine D2 receptor availability by measuring D2 Receptor Binding Potential (D2BP) using both \[18F\]Fallypride and \[11C\]Raclopride in pseudorandom order during days 2-5 of the inpatient stay.
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Age, Continuous
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31.67 years
STANDARD_DEVIATION 7.25 • n=5 Participants
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Sex: Female, Male
Female
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40 Participants
n=5 Participants
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Sex: Female, Male
Male
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21 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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7 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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32 Participants
n=5 Participants
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Race (NIH/OMB)
White
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18 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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3 Participants
n=5 Participants
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BMI
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30.09 kg/m^2
STANDARD_DEVIATION 8.21 • n=5 Participants
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PRIMARY outcome
Timeframe: assessed at Days 2-5Population: Only 54 participants completed striatal D2 Receptor Binding Potential (D2BP) as measured by \[18F\]Fallypride and \[11C\]Raclopride.
Correlations between striatal D2BP via \[18F\]Fallypride and striatal D2BP via \[11C\]Raclopride is obtained. Pearson's correlation coefficient is used with a possible range between -1 to 1 indicating strong association in the same direction as correlation is closer to 1, strong association in opposite direction as correlation is closer to -1, and no association as correlation is closer to 0.
Outcome measures
| Measure |
Dopamine D2/3 Receptor Antagonists
n=54 Participants
Healthy volunteers, within three Body Mass Index (BMI) strata, under controlled overnight fasting conditions following a period of dietary stabilization. The present study will attempt to resolve the controversy surrounding the relationship between BMI and dopamine D2 receptor availability by measuring D2 Receptor Binding Potential (D2BP) using both \[18F\]Fallypride and \[11C\]Raclopride in pseudorandom order during days 2-5 of the inpatient stay.
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Correlation Between Striatal D2 Receptor Binding Potential (D2BP) as Measured by [18F]Fallypride and [11C]Raclopride Time-activity Curves
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0.468 Correlation Coefficient
Interval 0.229 to 0.654
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PRIMARY outcome
Timeframe: assessed at Days 2-5Population: Only 57 participants had non-missing values of D2BP via \[18F\]Fallypride and 56 participants had non-missing values of D2BP via 11C\]Raclopride. Thus, the total number of participants analyzed is different for each of rows below.
Coefficient estimate of the quadratic term of BMI in quadratic regression is obtained and Coefficient estimate of the linear term of BMI in simple linear regression is obtained.
Outcome measures
| Measure |
Dopamine D2/3 Receptor Antagonists
n=61 Participants
Healthy volunteers, within three Body Mass Index (BMI) strata, under controlled overnight fasting conditions following a period of dietary stabilization. The present study will attempt to resolve the controversy surrounding the relationship between BMI and dopamine D2 receptor availability by measuring D2 Receptor Binding Potential (D2BP) using both \[18F\]Fallypride and \[11C\]Raclopride in pseudorandom order during days 2-5 of the inpatient stay.
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Relationship Between Striatal D2BP and BMI is Quadratic or Linear
Coefficeint of quadratic determination with D2BP Via [18F]Fallypride
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-0.022 Coefficient estimate
Interval -0.047 to 0.003
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Relationship Between Striatal D2BP and BMI is Quadratic or Linear
Coefficient of quadratic determination with D2BP Via [11C]Raclopride
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-0.001 Coefficient estimate
Interval -0.003 to 0.001
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Relationship Between Striatal D2BP and BMI is Quadratic or Linear
Coefficient of linear determination with D2BP Via [18F]Fallypride
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-0.032 Coefficient estimate
Interval -0.186 to 0.121
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Relationship Between Striatal D2BP and BMI is Quadratic or Linear
Coefficient of linear determination with D2BP Via [11C]Raclopride
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-0.027 Coefficient estimate
Interval -0.039 to -0.015
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PRIMARY outcome
Timeframe: assessed at Days 2-5Population: Only 50 participants had non-missing values of change in striatal dopamine D2BP after a palatable meal.
To determine the effect of palatable meal consumption on striatal D2BP using \[11C\]Raclopride
Outcome measures
| Measure |
Dopamine D2/3 Receptor Antagonists
n=50 Participants
Healthy volunteers, within three Body Mass Index (BMI) strata, under controlled overnight fasting conditions following a period of dietary stabilization. The present study will attempt to resolve the controversy surrounding the relationship between BMI and dopamine D2 receptor availability by measuring D2 Receptor Binding Potential (D2BP) using both \[18F\]Fallypride and \[11C\]Raclopride in pseudorandom order during days 2-5 of the inpatient stay.
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Change in Striatal Dopamine D2BP After a Palatable Meal
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-0.0164 Binding Potential
Standard Deviation 0.23
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PRIMARY outcome
Timeframe: assessed at Days 2-5Population: Only 50 participants had non-missing values of both change in striatal dopamine D2BP after palatable meal.
To determine association between change in striatal dopamine D2BP after a palatable meal consumption and BMI. Binding potential estimates will be estimated within subjects using \[11C\]Raclopride
Outcome measures
| Measure |
Dopamine D2/3 Receptor Antagonists
n=50 Participants
Healthy volunteers, within three Body Mass Index (BMI) strata, under controlled overnight fasting conditions following a period of dietary stabilization. The present study will attempt to resolve the controversy surrounding the relationship between BMI and dopamine D2 receptor availability by measuring D2 Receptor Binding Potential (D2BP) using both \[18F\]Fallypride and \[11C\]Raclopride in pseudorandom order during days 2-5 of the inpatient stay.
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Correlation Between Change in Striatal Dopamine D2BP After a Palatable Meal and BMI
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0.276 Correlation Coefficient
Interval -0.002 to 0.515
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SECONDARY outcome
Timeframe: assessed at Days 2-5Population: Only 54 participants had non-missing values of behavioral performance and striatal D2BP via \[18F\]Fallypride and 53 participants had non-missing values of behavioral performance and striatal D2BP via 11C\]Raclopride. Thus, the total number of participants analyzed is different for each of rows below.
Exploratory analyses of correlations between behavioral performance on Food Go/No Go computer task measured by No Go accuracy as commission errors and striatal D2BP via \[18F\]Fallypride and via \[11C\]Raclopride. Pearson's correlation coefficient is used with a possible range between -1 to 1 indicating strong association in the same direction as correlation is closer to 1, strong association in opposite direction as correlation is closer to -1, and no association as correlation is closer to 0.
Outcome measures
| Measure |
Dopamine D2/3 Receptor Antagonists
n=61 Participants
Healthy volunteers, within three Body Mass Index (BMI) strata, under controlled overnight fasting conditions following a period of dietary stabilization. The present study will attempt to resolve the controversy surrounding the relationship between BMI and dopamine D2 receptor availability by measuring D2 Receptor Binding Potential (D2BP) using both \[18F\]Fallypride and \[11C\]Raclopride in pseudorandom order during days 2-5 of the inpatient stay.
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Associations Between Behavioral Performance on Food Go/No Go Computer Task and Striatal D2BP
D2BP Via [18F]Fallypride
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0.156 Correlation Coefficient
Interval -0.116 to 0.407
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Associations Between Behavioral Performance on Food Go/No Go Computer Task and Striatal D2BP
D2BP Via [11C]Raclopride
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0.047 Correlation Coefficient
Interval -0.226 to 0.313
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SECONDARY outcome
Timeframe: assessed at Days 2-5Population: Only 53 participants had non-missing values of ad libitum meal consumption and striatal D2R via \[18F\]Fallypride and 52 participants had non-missing values of ad libitum meal consumption and striatal D2R via \[11C\]Raclopride. Thus, the total number of participants analyzed is different for each of rows below.
Exploratory analyses of correlations between eating behavior measured by ad libitum food intake at a single meal and striatal D2R via \[18F\]Fallypride and via \[11C\]Raclopride
Outcome measures
| Measure |
Dopamine D2/3 Receptor Antagonists
n=61 Participants
Healthy volunteers, within three Body Mass Index (BMI) strata, under controlled overnight fasting conditions following a period of dietary stabilization. The present study will attempt to resolve the controversy surrounding the relationship between BMI and dopamine D2 receptor availability by measuring D2 Receptor Binding Potential (D2BP) using both \[18F\]Fallypride and \[11C\]Raclopride in pseudorandom order during days 2-5 of the inpatient stay.
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Associations Between ad Libitum Meal Consumption and Striatal D2 Receptor (D2R)
D2R Via [18F]Fallypride
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-0.037 Correlation Coefficient
Interval -0.305 to 0.235
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Associations Between ad Libitum Meal Consumption and Striatal D2 Receptor (D2R)
D2R Via [11C]Raclopride
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-0.118 Correlation Coefficient
Interval -0.379 to 0.16
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SECONDARY outcome
Timeframe: assessed at Days 2-5Population: Only 33 participants had non-missing values of brain metabolite gamma-aminobutyric acid (GABA) via MRS and striatal D2BP via \[18F\]Fallypride. Thus, the total number of participants analyzed is different for each of rows below.
Exploratory analyses of correlations between brain metabolite GABA via magnetic resonance spectroscopy (MRS) and striatal D2BP via \[18F\]Fallypride. Pearson's correlation coefficient is used with a possible range between -1 to 1 indicating strong association in the same direction as correlation is closer to 1, strong association in opposite direction as correlation is closer to -1, and no association as correlation is closer to 0.
Outcome measures
| Measure |
Dopamine D2/3 Receptor Antagonists
n=33 Participants
Healthy volunteers, within three Body Mass Index (BMI) strata, under controlled overnight fasting conditions following a period of dietary stabilization. The present study will attempt to resolve the controversy surrounding the relationship between BMI and dopamine D2 receptor availability by measuring D2 Receptor Binding Potential (D2BP) using both \[18F\]Fallypride and \[11C\]Raclopride in pseudorandom order during days 2-5 of the inpatient stay.
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Associations Between Brain Metabolite GABA Via MRS and Striatal D2BP Via [18F]Fallypride
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-0.254 Correlation Coefficiant
Interval -0.549 to 0.098
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Adverse Events
Dopamine D2/3 Receptor Antagonists
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dopamine D2/3 Receptor Antagonists
n=61 participants at risk
Healthy volunteers, within three Body Mass Index (BMI) strata, under controlled overnight fasting conditions following a period of dietary stabilization. The present study will attempt to resolve the controversy surrounding the relationship between BMI and dopamine D2 receptor availability by measuring D2 Receptor Binding Potential (D2BP) using both \[18F\]Fallypride and \[11C\]Raclopride in pseudorandom order during days 2-5 of the inpatient stay.
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Musculoskeletal and connective tissue disorders
Myalgia
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1.6%
1/61 • Number of events 1 • 1 year
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Skin and subcutaneous tissue disorders
Urticaria
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1.6%
1/61 • Number of events 1 • 1 year
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Gastrointestinal disorders
Nausea
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1.6%
1/61 • Number of events 1 • 1 year
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place