Effect of weight status and different weight-loss methods on gut-brain interactions
- Conditions
- 10003018corpulenceObesitasobesitymorbidly overweight
- Registration Number
- NL-OMON43908
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 45
In order to be eligible to be included in the RYGB subject group of this study, a subject must qualify for weight loss surgery with RYGB, as evaluated by a physician at intake for surgery.
Furthermore, ALL subjects (RYGB, VLCD and Control) must meet all of the following criteria:
- Subject, male or female, is age 18 to 60 years of age.
- Subject must be able to understand and be willing to sign an informed consent document.
- Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study.
- For the RYGB group: subject has a body mass index (BMI) of 30 to 45 plus one or more co-morbid diseases expected to improve with weight loss, including but not limited to hypertension, dyslipidemia, obstructive sleep apnea, or diabetes mellitus, as evaluated by physician at intake. For the VLCD and control group: subject has a BMI of > 30 * 45.
- Subject must be of sufficient and stable medical health, as evaluated by physician at intake.
- Subjects included in the RYGB subject group must have failed standard obesity therapy of diet, exercise, behaviour modification, and pharmacologic agents either alone or in combination, as assessed at the intake for surgery by a physician.
- For the fMRI measurements inclusion criteria are as follows: not having any metallic fragments in the body, being right-handed. Because of the different brain laterality in left- and right-handed subjects we chose to include only right-handed subjects. Hence the results can be compared between the subjects.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease, by physician at intake.
- Subject has had significant weight loss in the last 3 months (>5kg).
- Subject has a history or is diagnosed with eating disorders.
- Subject has renal and/or hepatic insufficiency, by physician at intake.
- Subject has thyroid disease, which is not controlled with medication, as evaluated by physician at intake.
- Female subject who is pregnant (i.e., has a positive urine or blood pregnancy test prior to the procedure), is suspected to be pregnant, is lactating or is of childbearing potential but refuses to use adequate contraception during the study.
- Female subject who started birth control pills less than 3 months before enrollment, or who plans to start taking birth control pills during the study.
- Subjects who cannot discontinue either prescription or over the counter weight loss medications for at least 30 days prior to the start of the study as well as during the trial period.
- Subjects who have started medications within the last 3 months that are known to cause weight gain.
- Subjects who have cardiac pacemakers or other electronic implantable devices.
- Subjects who have psychiatric disease including but not limited to manic-depressive disorder, schizophrenia, borderline personality disorder, depression or suicidal tendencies.
- Subject currently uses or has a history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day).
- Subject has participated in a clinical study with an investigational new drug, biological, or therapeutic device within * 28 days prior to enrollment in this study, and does not agree to abstain from participation in other clinical trials of any kind during this study.
- Presence of contra-indications for f-MRI, as mentioned in the screening form and informed consent of the faculty of psychology (see section E2 and F1).
- Claustrophobia
- Being left-handed
- Metallic fragments in the body
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the optimal interaction of gut hormones and brain activity for<br /><br>successful weight loss and sustained weight maintenance this study will examine<br /><br>the effect of interaction of gastrointestinal hormone release on neural network<br /><br>activation through a) caloric restriction; b) caloric restriction with<br /><br>malapsorption or c) weight stability on food reward processing and decision<br /><br>making in the brain as well as on gastrointestinal hormone release.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Secondary contributions to this main parameter are:<br /><br>changes in body composition<br /><br>changes in hunger perception (TFEQ)</p><br>