About this trial
Bariatric surgery (BS), especially procedures like Sleeve Gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB), is the most effective treatment for obesity. Yet, the exact mechanisms governing its effect are somewhat elusive, with current research mainly focusing on post-operative food intake outcomes based on self-reported data, which might not fully capture the nuanced changes in eating behaviours.
To address these gaps, our study plans to employ the newly developed "drinkometer", a device capable of analysing the intricate changes in drinking behaviour following BS. This tool promises to bring a more detailed perspective to the changes in ingestive behaviours, bypassing the inaccuracies of self-reporting methods. By expanding our research to encompass diverse patient demographics and examining potential links to physiological shifts like gut hormone level alterations, the study aims to provide a more rounded understanding of the long-term impacts of BS on eating behaviours.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 year
BMI ≥ 35 kg/m2 for patients with planned RYGB or SG operation
BMI ≥ 30 kg/m2 for external controls affected by obesity but no planned RYGB or SG within the next 12 months, and
BMI ≥ 18.5 kg/m2 and ≤ 24.9 kg/m2 for controls without obesity.
Disqualifiers
history of previous bariatric operations and/ or revisional surgery (e.g., alteration of limb lengths after primary RYGB),
smoking,
established diagnosis of type 1 or 2 diabetes mellitus, and
polycystic ovary syndrome (PCOS).
Trial population
Participants with obesity and scheduled for bariatric surgery are recruited consecutively at the outpatient clinic of bariatric surgery at the University Hospital Zurich. Participants with obesity not scheduled for surgery are recruited at the private clinic "Adimed" in Winterthur. Participants without obesity are recruited from students, employees and faculty of the Faculty of Medicine of the University of Zurich.
Trial design
Cohort
Prospective
Treatments tested in this trial
Bariatric Surgery
Procedure/SurgeryThe intervention is not assigned to the participant after recruitment in the study, rather the intervention is an inclusion criteria for participation in the study.
Treatment groups
8
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Drinkometer Measurement of Microstructural Parameters of Ingestive Behaviour, such as Suck Energy Intake and Burst Energy Intake.
Difference of the eleven microstructural parameters of ingestive behaviour within the cohorts with intervention at the end of follow-up compared to baseline measurements and differences between the cohorts with intervention and the cohorts without intervention will be measured with a drinkometer device. The microstructural parameters of ingestive behaviour are: mean suck energy intake (kcal), mean suck duration (s), mean suck rate (kcal/s), mean suck maximal rate (kcal/s), burst number (n), burst energy intake (kcal), burst duration (s), burst rate (kcal/s), number of sucks per burst (n), inter-burst intervals (s), and inter-suck intervals (s). On this platform, a separate entry for the eleven microstructural parameters is not done to avoid redundancy in the description.
Effect of the Gut Hormones in Plasma on the Microstructural Parameters of Ingestive Behaviour Measured with the Drinkometer Device
This study investigates the effect of pre- and post-prandial levels of gut hormones on the eleven microstructural parameters of ingestive behavior. These are: mean suck energy intake (kcal), mean suck duration (s), mean suck rate (kcal/s), mean suck maximal rate (kcal/s), burst number (n), burst energy intake (kcal), burst duration (s), burst rate (kcal/s), number of sucks per burst (n), inter-burst intervals (s), and inter-suck intervals (s). On this platform, a separate entry for the eleven microstructural parameters is not done to avoid redundancy in the description. The study focuses on the influence of the following gut hormones: leptin, ghrelin, cholecystokinin (CCK), glucagon-like peptide-1 (GLP-1), gastric inhibitory polypeptide (GIP), amylin, peptide YY (PYY), and insulin. These hormone concentrations are measured both pre- and post-prandially in the blood and are expressed in their respective units of measure (e.g., leptin in ng/mL, ghrelin in pg/mL).
Effect of Biological Sex (Male or Female) on the Microstructural Parameters of Ingestive Behaviour Measured with the Drinkometer Device
This study investigates the effect of biological sex (male or female) on the eleven microstructural parameters of ingestive behavior. These parameters are: mean suck energy intake (kcal), mean suck duration (s), mean suck rate (kcal/s), mean suck maximal rate (kcal/s), burst number (n), burst energy intake (kcal), burst duration (s), burst rate (kcal/s), number of sucks per burst (n), inter-burst intervals (s), and inter-suck intervals (s). On this platform, a separate entry for the eleven microstructural parameters is not done to avoid redundancy in the description. The study focuses on comparing these parameters between males and females to understand the influence of biological sex on ingestive behavior.
Cluster identification
Identification of clusters of good and poor response to RYGB five years after surgery based on the variance of the single microstructural parameters of ingestive behaviour
Sponsors and contacts
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University of Zurich
Lead sponsor
Florida State University
Collaborator
University College Dublin
Collaborator