Direct Measurement of Ingestive Behaviour in Relation to Sex Differences and Gastrointestinal Hormone Levels in Patients After Metabolic and Bariatric Surgery

ConditionObesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Zurich

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Bariatric Surgery

    Procedure/Surgery

    The 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

420 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Adult Females planned for RYGB surgery1 intervention
Group B: Adult Females planned for SG surgery1 intervention
Group C: Adult Females with Obesity0 interventions
Group D: Adult Females with Normal-Weight0 interventions
Group E: Adult Males planned for RYGB surgery1 intervention
Group F: Adult Males with Obesity0 interventions
Group G: Adult Males with Normal-Weight0 interventions
Group H: Adult Females and Males 5 years after RYGB surgery1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
One year after bariatric surgery
2

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).

Time frame
One year after bariatric surgery
3

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.

Time frame
One year after bariatric surgery
4

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

Time frame
Five years after bariatric surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Zurich

Lead sponsor

Florida State University

Collaborator

University College Dublin

Collaborator