|- candidate number||13505|
|- NTR Number||NTR3684|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-nov-2012|
|- Secondary IDs||2012_332 METC AMC|
|- Public Title||Long-term effects of bariatric surgery.|
|- Scientific Title||The long-term effects of bariatric surgery on metabolism, behavior and striatal dopamine receptors.|
|- Healt Condition(s) or Problem(s) studied||Obesity, Metabolic syndrome, Bariatric surgery, Dopamine receptors|
|- Inclusion criteria||Pre-menopausal Caucasian women that took part in our previous study "The pleiotropic effects of bariatric surgery" and underwent bariatric surgery > 1 year ago.|
|- Exclusion criteria||1. Use of medication which interferes with dopamine metabolism;|
4. Tobacco use (i.e. smokers);
5. Unwilling or unable to provide informed consent.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-dec-2012|
|- planned closingdate||1-dec-2013|
|- Target number of participants||19|
|- Primary outcome||Striatal dopamine D2/3 receptor availability.|
|- Secondary outcome||1. Plasma levels of several hormones, metabolites and peptides involved in appetite regulation and glucose metabolism;|
2. Behavioral parameters (measured via questionnaire and computer task).
|- Timepoints||This follow-up study will take place at one time point. The acquired data will be compared to the data acquired in the same patients in our previous study 'The pleiotropic effects of bariatric surgery’ (MEC 08/161).|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. E.M. Zwaal, van der|
|- CONTACT for SCIENTIFIC QUERIES|| M.J.M. Serlie|
|- Sponsor/Initiator ||Academic Medical Center (AMC)|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||Rationale: |
Bariatric surgery is the only effective way to induce sustained weight loss and reversal of the obesity-induced changes in lipid and glucose metabolism. Insight into the mechanisms underlying these highly desirable effects is crucial in the development of future treatment modalities for metabolic syndrome that do not involve the risks associated with surgery. Furthermore, gaining insight into the association between obesity and reduced striatal dopamine D2/3 receptor availability may provide valuable insight into the development of obesity and the metabolic syndrome and aid in the development of future treatment modalities.
To determine whether the reduced striatal dopamine D2/3 receptor availability in morbidly obese women is reversed by long term weight loss after bariatric surgery. In addition, behavioral parameters and regulating factors involved in appetite regulation and glucose homeostasis will be studied and compared to data obtained prior to surgery and 6 weeks after surgery in an earlier study with the same participants. These regulatory factors will be correlated to changes in striatal D2/3R availability.
Observational (follow-up) study.
19 pre-menopausal Caucasian women that previously participated in our study "The pleiotropic metabolic effects of bariatric surgery" and underwent Roux-en-Y gastric bypass surgery at least 1 year ago.
Main study parameters/endpoints:
1. Changes in striatal D2/D3 receptor availability more than 1 year after bariatric surgery in a weight stable phase as compared to pre-operative measurements;
2. Comparison of glucoregulatory hormones as well as regulating hormones and metabolites involved in appetite regulation, before versus 1 year after surgery, and in relation to changes in striatal D2/3 R availability;
3. Behavioral changes, before versus at least 1 year after bariatric surgery in a weight stable phase.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Subjects will visit the research centre once. The amount of blood withdrawn does not expose the participant to any medical risk. The exposure to radiation during SPECT scans is considered to be intermediate. The same questionnaires and behavioural tasks were performed by the subjects in the previous study and are not expected to cause any psychological discomfort.
|- Main changes (audit trail)|
|- RECORD||4-nov-2012 - 25-feb-2013|