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NCT03648892 · ClinicalTrials.gov registry record · Early Phase 1
Brain Dopamine Function in Human Obesity
A Early Phase 1 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 61
- Enrollment target
NCT03648892: Completed Early Phase 1 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT03648892 is a Early Phase 1 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 61 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03648892, a Early Phase 1 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 61 participants
- Enrollment target
Study 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 18.5 kg/m2 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 PET/MRI 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 likes/dis-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
Primary Outcome
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.
Interventions
- DRUG [c11] raclopride
- DRUG [18F]fallypride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2018-09-21 |
| Est. Completion | 2023-02-17 |
| Phase | Early Phase 1 |
What the finished NCT03648892 record still lists
NCT03648892 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 2 interventions - of which [c11] raclopride is the first listed.
NCT03648892 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03648892 about?
NCT03648892 is a clinical study titled "Brain Dopamine Function in Human Obesity". 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 dopami...
What is the current status of trial NCT03648892?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 61 participants. The study started on 2018-09-21. Estimated completion is 2023-02-17.
What interventions are being tested in trial NCT03648892?
The interventions under investigation include: [c11] raclopride (DRUG), [18F]fallypride (DRUG).
Who is sponsoring clinical trial NCT03648892?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03648892's enrollment target sits among peer trials
61 397th of 2000 higher than 1,599 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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