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

NCT ID: NCT05359887

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Unsuccessful BS (Total Weight Loss (TWL) < 20%)

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

Group Type EXPERIMENTAL

standardized liquid mixed meal Nutridrink®

Intervention Type OTHER

Administration of food in controlled situation

Successful BS (TWL > 25%).

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

Group Type EXPERIMENTAL

standardized liquid mixed meal Nutridrink®

Intervention Type OTHER

Administration of food in controlled situation

Interventions

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standardized liquid mixed meal Nutridrink®

Administration of food in controlled situation

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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MCL

Leeuwarden, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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D.L. Marinus Oterdoom, MD

Role: CONTACT

+31503612837

Andre P. van Beek, MD PhD

Role: CONTACT

Facility Contacts

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Marlous Emous

Role: primary

Other Identifiers

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UMCG202100632

Identifier Type: -

Identifier Source: org_study_id

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