Ignite Creation Date:
2024-05-06 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03648892
Status:
COMPLETED
Last Update Posted:
2023-07-11
First Post:
2018-08-24
Brief Title:
Brain Dopamine Function in Human Obesity
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Brain Dopamine Function in Human Obesity
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Dopamine is a natural chemical in the brain that may influence eating behavior and physical activity Researchers want to measure the brain s dopamine activity and understand how it differs in people with obesity
Objective
To better understand how brain function particularly dopamine activity relates to body weight and eating behavior
Individuals may be able to participate if they
Have a BMI of at least 185 kgm2
Are weight-stable and generally healthy
Are between ages 18-45 years
Have normal blood pressure
Are not using illegal drugs based on urine drug screen
Are not following a special diet
Do not have metal implants
Design
Participants will be screened with
Medical history
Physical exam
Questionnaires and an interview to see if it is safe to have a PETMRI scan
Fasting blood and urine tests
Participants will eat a special diet given to them for the 5 days before their inpatient visit
Participants will have a 5-day inpatient visit Some days include blood and urine tests Each day includes surveys and tests to measure habits and likesdis-likes A sample schedule may be
Day 1 Participants will wear a monitor that uses a needle below the skin to measure glucose Their body fat will be measured with low-dose x-rays
Day 2 Participants will have a PET scan They will lie on a table that slides in and out of a donut-shaped scanner They will be injected with a small amount of a radioactive substance and wear a cap on their head
Day 3 Participants will have an MRI They will lie on a table that slides in and out of a scanner
Day 4 Participants will have another PET scan This time they will drink a milk shake during a break from the scanner Then they will go back inside the scanner for the end of their scan
Day 5 Participants will wear a hood for up to 40 minutes to measure their breathing They will also drink special water and collect samples of their urine to measure the rate they burn energy
For 12 months after the visit participants will track their weight and physical activity daily using a special scale and activity monitor A few times over the year the study team will send participants special activity monitors to use for 7 days at a time
Participants will have an in-person 1-day follow-up visit This includes most tests except for PET scanning
Dopamine is a natural chemical in the brain that may influence eating behavior and physical activity Researchers want to measure the brain s dopamine activity and understand how it differs in people with obesity
Objective
To better understand how brain function particularly dopamine activity relates to body weight and eating behavior
Individuals may be able to participate if they
Have a BMI of at least 185 kgm2
Are weight-stable and generally healthy
Are between ages 18-45 years
Have normal blood pressure
Are not using illegal drugs based on urine drug screen
Are not following a special diet
Do not have metal implants
Design
Participants will be screened with
Medical history
Physical exam
Questionnaires and an interview to see if it is safe to have a PETMRI scan
Fasting blood and urine tests
Participants will eat a special diet given to them for the 5 days before their inpatient visit
Participants will have a 5-day inpatient visit Some days include blood and urine tests Each day includes surveys and tests to measure habits and likesdis-likes A sample schedule may be
Day 1 Participants will wear a monitor that uses a needle below the skin to measure glucose Their body fat will be measured with low-dose x-rays
Day 2 Participants will have a PET scan They will lie on a table that slides in and out of a donut-shaped scanner They will be injected with a small amount of a radioactive substance and wear a cap on their head
Day 3 Participants will have an MRI They will lie on a table that slides in and out of a scanner
Day 4 Participants will have another PET scan This time they will drink a milk shake during a break from the scanner Then they will go back inside the scanner for the end of their scan
Day 5 Participants will wear a hood for up to 40 minutes to measure their breathing They will also drink special water and collect samples of their urine to measure the rate they burn energy
For 12 months after the visit participants will track their weight and physical activity daily using a special scale and activity monitor A few times over the year the study team will send participants special activity monitors to use for 7 days at a time
Participants will have an in-person 1-day follow-up visit This includes most tests except for PET scanning
Detailed Description:
Evidence from neuroimaging studies indicates that aberrant functionality in brain regions that support reward processing and habit formation may be related to an individuals eating behavior and obesity propensity In particular our previous research found that increased dopamine D2 receptor binding potential D2BP in the dorsal and lateral striatum was positively related to opportunistic eating behaviors body fat and body mass index BMI However our findings were contrary to highly-cited previous reports of D2BP correlating with BMI in the opposite direction The primary aim of this study is to elucidate the reasons for the conflicting results that used somewhat different methodologies Specifically our previous study used positron emission tomography PET to measure D2BP using the dopamine D2 receptor antagonist radioligand 18Ffallypride following a period of dietary stabilization and 3 hours after a standardized breakfast Reports finding correlations between D2BP and BMI in the opposite direction have typically investigated subjects with higher BMI using the D2 receptor antagonist radioligand 11Craclopride Furthermore previous studies were typically conducted in the fasted state but the subjects prior food intake was not well-controlled The present study will attempt to resolve the controversy by measuring D2BP using both 18Ffallypride and 11Craclopride in 39 adults 13 within each of three BMI strata to represent a large BMI range under controlled overnight fasting conditions following a period of dietary stabilization The primary aims are to estimate the mathematical relationship between striatal D2BP and BMI and determine the within-subject correlations of D2BP derived from 18Ffallypride and 11Craclopride
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 18-DK-0132 | None | None | None |