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

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
standardized liquid mixed meal Nutridrink®
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity focused on measuring Obesity, Reward system, PET-scan, [11C]-Raclopride

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MCLRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

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

Successful BS (TWL > 25%).

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 12, 2022
Last Updated
May 11, 2023
Sponsor
University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT05359887
Brief Title
PET-study on the Role of the Reward System in Weight Loss After Bariatric Surgery
Acronym
ObesiPET
Official Title
PET-study on the Role of the Reward System in Weight Loss After Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medical Center Groningen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Reward system, PET-scan, [11C]-Raclopride

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unsuccessful BS (Total Weight Loss (TWL) < 20%)
Arm Type
Experimental
Arm Description
Fifteen who had unsuccessful BS (Total Weight Loss (TWL) < 20%)
Arm Title
Successful BS (TWL > 25%).
Arm Type
Experimental
Arm Description
Fifteen who had successful BS (TWL > 25%).
Intervention Type
Other
Intervention Name(s)
standardized liquid mixed meal Nutridrink®
Intervention Description
Administration of food in controlled situation
Primary Outcome Measure Information:
Title
Change in [11C]-raclopride binding potential in the brain's reward system between study groups before and after a food challenge.
Description
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
Time Frame
-50 minutes (before start of PET scanning), 0 minutes (during PET break, before mixed meal), 30 minutes (after second phase of PET-scanning)
Secondary Outcome Measure Information:
Title
The correlation between [11C]-raclopride binding potential in the brain's reward system and of questionnaires and diaries
Description
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.
Time Frame
Pre-intervention
Title
The correlation between [11C]-raclopride binding potential in the brain's reward system and of gut hormones.
Description
The relation between fasting or fed (gut) hormone concentrations and dopamine D2 receptor availability in the reward system.
Time Frame
-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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
D.L. Marinus Oterdoom, MD
Phone
+31503612837
Email
d.l.m.oterdoom@umcg.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Andre P. van Beek, MD PhD
Email
a.p.van.beek@umcg.nl
Facility Information:
Facility Name
MCL
City
Leeuwarden
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marlous Emous

12. IPD Sharing Statement

Plan to Share IPD
No

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

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