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

Obesity Clinical Trial

— ObesiPET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05359887
• Other study ID #: UMCG202100632
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University Medical Center Groningen
• Contact: D.L. Marinus Oterdoom, MD
• Phone: +31503612837
• Email: d.l.m.oterdoom[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
Netherlands	MCL	Leeuwarden

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in [11C]-raclopride binding potential in the brain's reward system between study groups before and after a food challenge.	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	-50 minutes (before start of PET scanning), 0 minutes (during PET break, before mixed meal), 30 minutes (after second phase of PET-scanning)
Secondary	The correlation between [11C]-raclopride binding potential in the brain's reward system and of questionnaires and diaries	The correlation between questionnaires on eating habits (EDE-Q, REO, YFAS) and quality of life (OBESI-Q) in patients who had successful vs unsuccessful BS and [11C]-raclopride binding potential.	Pre-intervention
Secondary	The correlation between [11C]-raclopride binding potential in the brain's reward system and of gut hormones.	The relation between fasting or fed (gut) hormone concentrations and dopamine D2 receptor availability in the reward system.	-50 minutes (before start of PET scanning), 0 minutes (during PET break, before mixed meal), 30 minutes (after second phase of PET-scanning), 60 - 90 - 120 minutes