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

NCT06538948 | Recruiting

• 1 other identifier: 2023-02109
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Obesity

Keywords

Obesity; Ingestive Behaviour; Bariatric Surgery; Gut Hormones; Drinkometer

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (8)

Adult Females planned for RYGB surgery

Adult females leaving with obesity with BMI between 35 and 50 kg/m2 and scheduled for Roux-en-Y Gastric Bypass Surgery

Procedure: Bariatric Surgery

Adult Females planned for SG surgery

Adult females leaving with obesity with BMI between 35 and 50 kg/m2 and scheduled for Sleeve Gastrectomy Surgery

Procedure: Bariatric Surgery

Adult Females with Obesity

Adult females leaving with obesity with BMI between 30 and 50 kg/m2 but not scheduled for any procedures of bariatric surgery

Adult Females with Normal-Weight

Adult females with normal weight with BMI between 18.5 and 24.9 kg/m2

Adult Males planned for RYGB surgery

Adult males leaving with obesity with BMI between 35 and 50 kg/m2 and scheduled for Roux-en-Y Gastric Bypass Surgery

Procedure: Bariatric Surgery

Adult Males with Obesity

Adult males leaving with obesity with BMI between 30 and 50 kg/m2 but not scheduled for any procedures of bariatric surgery

Adult Males with Normal-Weight

Adult males with normal weight with BMI between 18.5 and 24.9 kg/m2

Adult Females and Males 5 years after RYGB surgery

Adult Females and Males who underwent RYGB surgery 5 years before study recruitment and study measurements

Procedure: Bariatric Surgery

Interventions

Bariatric Surgery PROCEDURE

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.

Adult Females and Males 5 years after RYGB surgery; Adult Females planned for RYGB surgery; Adult Females planned for SG surgery; Adult Males planned for RYGB surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Zurich: lead
• Florida State University: collaborator
• University College Dublin: collaborator

Study Sites (2)

Hospital Männedorf

Männedorf, Canton of Zurich, 8708, Switzerland

RECRUITING

University Hospital Zurich, Department of Surgery and Transplantation

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Related Publications (7)

• Gero D, Steinert RE, le Roux CW, Bueter M. Do Food Preferences Change After Bariatric Surgery? Curr Atheroscler Rep. 2017 Sep;19(9):38. doi: 10.1007/s11883-017-0674-x.

  PMID: 28779431 BACKGROUND

• le Roux CW, Bueter M. The physiology of altered eating behaviour after Roux-en-Y gastric bypass. Exp Physiol. 2014 Sep;99(9):1128-32. doi: 10.1113/expphysiol.2014.078378.

  PMID: 25210112 BACKGROUND

• Gero D, File B, Alceste D, Frick LD, Serra M, Ismaeil AE, Steinert RE, Spector AC, Bueter M. Microstructural changes in human ingestive behavior after Roux-en-Y gastric bypass during liquid meals. JCI Insight. 2021 Aug 9;6(15):e136842. doi: 10.1172/jci.insight.136842.

  PMID: 34369388 BACKGROUND

• Alceste D, Serra M, Raguz I, Gero D, Thalheimer A, Widmer J, File B, Ismaeil A, Steinert RE, Spector AC, Bueter M. Association between microstructure of ingestive behavior and body weight loss in patients one year after Roux-en-Y gastric bypass. Physiol Behav. 2022 May 1;248:113728. doi: 10.1016/j.physbeh.2022.113728. Epub 2022 Feb 5.

  PMID: 35134394 BACKGROUND

• Lutz TA, Bueter M. Physiological mechanisms behind Roux-en-Y gastric bypass surgery. Dig Surg. 2014;31(1):13-24. doi: 10.1159/000354319. Epub 2014 May 8.

  PMID: 24819493 BACKGROUND

• Gero D, File B, Justiz J, Steinert RE, Frick L, Spector AC, Bueter M. Drinking microstructure in humans: A proof of concept study of a novel drinkometer in healthy adults. Appetite. 2019 Feb 1;133:47-60. doi: 10.1016/j.appet.2018.08.012. Epub 2018 Sep 1.

  PMID: 30179650 BACKGROUND

• Serra M, File B, Alceste D, Raguz I, Gero D, Thalheimer A, Widmer J, Ismaeil A, Steinert RE, Spector AC, Bueter M. Burst-pause criterion derivation for drinkometer measurements of ingestive behavior. MethodsX. 2022 May 11;9:101726. doi: 10.1016/j.mex.2022.101726. eCollection 2022.

  PMID: 35620756 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples are collected from venous blood before, directly after, 30, and 90 minutes after the meal test. Plasma samples will be isolated from blood samples and stored at -80° C for later analysis. The analysis of DNA is not planned in this study. Nevertheless, plasma can contain cell-free DNA (cfDNA). Considering that no solution for the stabilisation of nucleic acid is added to the plasma samples, a complete or meaningful sequencing of the cfDNA can hardly be expected from the plasma samples collected in this study.

MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Marco Bueter, MD, DPhil

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Bueter, MD, DPhil

CONTACT

+41442558895; m.bueter@spitalmaennedorf.ch

Michele Serra, PhD

CONTACT

+41762226763; michele.serra@uzh.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Bariatric Surgery

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 6, 2024
• Study Start: February 13, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)