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Active, not recruiting Not applicable

PET-study on the Role of the Reward System in Weight Loss After Bariatric Surgery

NCT05359887 · tracked via the Priya Life Science Netherlands tracker
Phase
Not applicable
Started
2022-12-01
Last updated
2026-04-29

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

standardized liquid mixed meal Nutridrink®

standardized liquid mixed meal Nutridrink®: Administration of food in controlled situation

Study summary

Bariatric surgery (BS) is currently the most effective treatment in severe obesity. However, a considerable percentage of patients undergoing BS fail to lose sufficient weight or regain weight after initial weight loss during long-term follow-up, which may be attributed to personality traits and pathological eating behaviour. Previous positron emission tomography (PET) studies have shown reduced dopamine D2 receptor availability in obese patients and upregulation of this availability following successful BS in the brain's reward system. Dopamine D2 receptor availability in patients with unsuccessful BS has not been investigated to date.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Bariatric surgery 24-36 months prior to the study * Adult (over 18y old) * Mentally capable to understand the consequences of the procedure and make his or her own choice without coercion * Able to undergo PET and MRI, according to the investigator's assessment * Native speaking * Able to participate in follow-up * Written informed consent Exclusion Criteria: * Presence of a DSM-IV axis 1 disorder * The use of drugs that bind to dopamine D2/3 receptors, including various classes of antipsychotics and antidepressants * History of stroke, brain tumor, Parkinson's Disease or dementia * History of head trauma with loss of consciousness * Alcohol or substance abuse in the last 6 months * Alcohol consumption 24h prior to PET scanning * Smoking or other forms of nicotine intake 12 hours prior to PET scanning * Use of anorectic drugs in the last 6 months * Current pregnancy * Medication for Diabetes Mellitus * Claustrophobia * The presence of implanted metal objects of the type which may concentrate radiofrequency fields or cause tissue damage from twisting in a magnetic field (such as certain implanted devices, shrapnel, ocular metal shavings) * Patients with a bodyweight \> 200kg will be excluded to ensure the maximum load of the camera bed of the PET-scanner (227 kg) is not exceeded.

Primary outcome measure(s)

  • Change in [11C]-raclopride binding potential in the brain's reward system between study groups before and after a food challenge. — -50 minutes (before start of PET scanning), 0 minutes (during PET break, before mixed meal), 30 minutes (after second phase of PET-scanning)
    Pre- and post-eating changes in dopamine D2 receptor availability as indexed by the \[11C\]-raclopride binding potential in the brain's reward system between subjects who underwent successful vs unsuccessful bariatric surgery

Trial sites (1)

FacilityCityRegionStatus
MCL Leeuwarden Netherlands
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05359887 on ClinicalTrials.gov ↗ ← All trials in the Netherlands