To compare dopamine D2 receptor availability before and after a food challenge in patients who underwent successful BS or unsuccessful BS.
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
- Eating disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pre- and post-eating differences 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
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 relation between fasting or fed (gut) hormone concentrations and dopamine
D2 receptor availability in the reward system .
Background 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.
Study objective
To compare dopamine D2 receptor availability before and after a food challenge
in patients who underwent successful BS or unsuccessful BS.
Study design
An explorative interventional study
Intervention
Standardized liquid mixed meal Nutridrink®
Study burden and risks
Patients are asked to fill out questionnaires. Questionnaires are handed to the
patients or instructions to fill out these questionnaires online are given.
Patient will receive an appointment in the UMCG:
- Welcome and instructions (outline of the day)
- Placement of venous catheter
- PET (first part; 50 minutes)
- Standard mixed meal intake (10 minutes)
- PET (second part; 30 minutes)
- Blood sampling/VAS hunger and satiety
o t = -50 minutes (before start of PET scanning)
o t = 0 minutes (during PET break, before mixed meal)
o t = 30 minutes (after second phase of PET-scanning)
o t = 60 - 90 - 120 minutes (after mixed meal)
- Removal of venous catheter
- MRI (may also be performed at start of protocol, or on another day)
The injected mass of [11C]-raclopride is small (<10 µg/dose) and idiosyncratic
reactions are rare to occur for PET radiotracers. The only expected adverse
event can be a bruise as a result of the placement of a venous catheter for
tracer injection. Since the PET tracer is radioactive, the subjects are exposed
to radiation. The radiation burden of the total [11C]-raclopride dose of 380
MBq is estimated to be 2.7 mSv, and the total radiation burden, including the
low-dose CT scans for attenuation will be 3.7mSv, which is within the category
IIb, minor to moderate risk (1-10 mSv) according to ICRP62. In comparison, the
radiation level of natural background sources in the Netherlands is about 2.5
mSv per year.
Blood samples (gut hormones, insulin and blood glucose levels) are taken from
the second venous catheter on six moments before and after the mixed meal with
a total volume of 100ml.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
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
- 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
- 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79187.042.22 |
| Other | nummer is aangevraagd |