Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538948
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Direct Measurement of Ingestive Behaviour in Relation to Sex Differences and Gastrointestinal Hormone Levels in Patients After Metabolic and Bariatric Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Direct Measurement of Ingestive Behaviour in Relation to Sex Differences and Gastrointestinal Hormone Levels in Patients After Metabolic and Bariatric Surgery
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIBASH
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
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
Detailed Description:
HYPOTHESIS AND PRIMARY OBJECTIVE
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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None