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

Sponsor
University Medical Center Groningen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05359887
Collaborator
(none)
30
Enrollment
2
Arms
21
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: standardized liquid mixed meal Nutridrink®
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
PET-study on the Role of the Reward System in Weight Loss After Bariatric Surgery
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Unsuccessful BS (Total Weight Loss (TWL) < 20%)

Fifteen who had unsuccessful BS (Total Weight Loss (TWL) < 20%)

Other: standardized liquid mixed meal Nutridrink®
Administration of food in controlled situation
Experimental: Successful BS (TWL > 25%).

Fifteen who had successful BS (TWL > 25%).

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

Outcome Measures

Primary Outcome Measures

  1. 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

Secondary Outcome Measures

  1. The correlation between [11C]-raclopride binding potential in the brain's reward system and of questionnaires and diaries [Pre-intervention]

    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.

  2. The correlation between [11C]-raclopride binding potential in the brain's reward system and of gut hormones. [-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]

    The relation between fasting or fed (gut) hormone concentrations and dopamine D2 receptor availability in the reward system.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Medical Center Groningen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Medical Center Groningen
ClinicalTrials.gov Identifier:
NCT05359887
Other Study ID Numbers:
  • UMCG202100632
First Posted:
May 4, 2022
Last Update Posted:
May 4, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Medical Center Groningen
Obesity
Reward system
PET-scan
[11C]-Raclopride
Additional relevant MeSH terms:
Weight Loss

Study Results

No Results Posted as of May 4, 2022