Direct Measurement of Ingestive Behaviour in Relation to Sex Differences and Gastrointestinal Hormone Levels in Patients After Metabolic and Bariatric Surgery
NCT ID: NCT06538948
Last Updated: 2024-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
420 participants
OBSERVATIONAL
2024-02-13
2027-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Microstructure of Ingestive Behavior and Body Weight Loss After Roux-en-Y Gastric Bypass
NCT04933305
Direct Measurement of Food Intake Behaviour in Obese Women Before and After Bariatric Surgery or Lifestyle Intervention
NCT04990947
Physiological Effects of Gastric Sleeve Operation
NCT03046186
Food Preference Following Bariatric Surgery
NCT03363581
Investigation of the Effects of Obesity Surgery on Appetitive Behaviour
NCT02010385
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
So far, studies of ingestive behaviour in humans have produced ambiguous results. Moreover, direct measurements of ingestive behaviour in humans after BS are still rare and the roles of sex and gut hormones, as well as their relevance for clinical outcome parameters, such as body weight loss, remain elusive. A comprehensive understanding of how a given intervention such as BS affects food intake requires a detailed analysis of the ingestive behaviour itself, not simply the measurement of the outcome of the behaviour. In other words, the information on how the food is consumed is equally or even more important than the information on how much food has been ingested.
This study employs the drinkometer methodology to perform direct measurements of ingestive behaviour in male and female human patients after SG and RYGB along with parallel measurements of postprandial gut hormone levels. Furthermore, this study investigates the clinical relevance of changes in ingestive behaviour by correlating microstructural parameters with body weight loss in a consecutive set of patients who received RYGB at the University Hospital Zurich five years before the time of recruitment.
Of note, the proposed experiments aim to test specific hypotheses regarding the behavioural mechanisms underlying potential changes in food intake after BS in humans. Thus, this research do not aim to identify how BS affects one or the other single microstructural parameters of eating or drinking. Instead, this study investigates how a given intervention that is known to substantially affect food intake behaviour - such as BS - alters the profile of a group of microstructural parameters of ingestive behaviour in humans. Given that ingestive behaviour represents the readout of the central nervous system mechanisms controlling energy intake (e.g., palatability, aversion, avoidance, satiation), the results of the proposed studies will inform the search for the underlying neural circuits in the brain that are specifically altered by BS. If there is no altered behaviour, there would be no point in investigating the underlying physiology. More specifically, this study aims to:
1. Investigate longitudinal changes and differences in the ingestive behaviour of female patients before and within one year after either primary RYGB or primary SG (Study 1).
2. Investigate a possible association between the ingestive behaviour and the prandial gut hormone levels of female patients before and within one year after either primary RYGB or SG (Study 1).
3. Investigate a possible difference between the ingestive behaviour of female and male patients before and within one year after primary RYGB (Study 2).
4. Investigate a possible association between the postoperatively achieved body weight loss of female and male patients 5 years after primary RYGB and ingestive behaviour (Study 3).
5. Investigate, in a subset of responders and non-responders to primary RYGB, a possible association between postprandial gut hormone levels of female and male patients 5 years after primary RYGB and ingestive behaviour (Study 3).
PRIMARY AND SECONDARY ENDPOINTS
In the research protocol, the primary and secondary outcomes specific to each of the three studies planned within the research project have been described. Recognising that each study has its unique objectives and hypotheses, the outcomes have been specified distinctly for each study to ensure clarity and focus in the research approach.
For each of the three studies, the primary outcomes are those key results that the study is primarily designed to assess. These are the main effects or findings that are anticipated to provide the most significant insights into the research questions. Secondary outcomes, while still important, are additional results that can be explored after answering the main research questions. These might provide supplementary information, support the primary outcomes, or offer insights into other areas related to the main research question.
By presenting these outcomes separately for each study, this study aims to provide a structured and transparent overview of the research intentions, allowing for a clear understanding of the objectives and measures in each specific part of the project. This approach not only aids in maintaining the focus and integrity of each study but also assists in the clear communication of the research goals and methods.
PROJECT DESIGN
The proposed studies will test key elements of ingestive behaviour and their relation to pre- and postprandial levels of gut hormones as well as sex differences after the two most frequently performed bariatric operations. They will thus provide useful information for planning and conducting future trials in the field, such as optimal recruitment and retention strategies, intervention delivery, data collection methods and adherence to study protocols. The proposed studies will further provide empirical estimates of effect sizes of bariatric surgery and long-term associations of ingestive behaviour with gut hormones for post-bariatric body weight loss. The potential outcomes of Studies 1, 2 and 3 are conceptually different. Nevertheless, the results of these studies will complement each other as well as our findings from previous studies, and can be used to calculate sample sizes for future trials.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Bariatric 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.
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
Bariatric 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.
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
No interventions assigned to this group
Adult Females with Normal-Weight
Adult females with normal weight with BMI between 18.5 and 24.9 kg/m2
No interventions assigned to this group
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
Bariatric 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.
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
No interventions assigned to this group
Adult Males with Normal-Weight
Adult males with normal weight with BMI between 18.5 and 24.9 kg/m2
No interventions assigned to this group
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
Bariatric 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bariatric 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* smoking,
* established diagnosis of type 1 or 2 diabetes mellitus, and
* polycystic ovary syndrome (PCOS).
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Florida State University
OTHER
University College Dublin
OTHER
University of Zurich
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marco Bueter
Head of Bariatric Surgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marco Bueter, MD, DPhil
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Männedorf
Männedorf, Canton of Zurich, Switzerland
University Hospital Zurich, Department of Surgery and Transplantation
Zurich, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-02109
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.