Direct Measurement of Ingestive Behaviour in Relation to Sex Differences and Gastrointestinal Hormone Levels in Patients After Metabolic and Bariatric Surgery
NCT Number: NCT06538948
Acronym: DIBASH
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Obesity
Interventions: PROCEDURE: Bariatric Surgery
Sponsor: University of Zurich
Collaborators: Florida State University|University College Dublin
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 420
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-13
Completion Date: 2027-08-31
Locations: Hospital Männedorf, Männedorf, Zurich, 8708, Switzerland|University Hospital Zurich, Department of Surgery and Transplantation, Zurich, 8091, Switzerland

Summary:
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.

Primary Outcome Measures: 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., One year after bariatric surgery|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)., One year after bariatric surgery|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., One year after bariatric surgery|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, Five years after bariatric surgery|Correlation of Percentage Excess Body Mass Index Loss with the Microstructural Parameters of Ingestive Behaviour Measured with the Drinkometer Device Five Years After Roux-en-Y Gastric Bypass Surgery, This study aims to investigate the correlation between percentage excess body mass index (BMI) loss (%EBMIL) and microstructural parameters of ingestive behavior, measured using the Drinkometer device, five years after Roux-en-Y gastric bypass (RYGB) surgery. The eleven microstructural parameters considered 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).

This study explores how these microstructural parameters of ingestive behavior correlate with the long-term success of RYGB surgery as indicated by %EBMIL. By understanding these correlations, we aim to gain insights into the behavioral mechanisms that contribute to the maintenance of weight loss post-surgery., Five years after bariatric surgery