Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287307
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-01
First Post:
2023-06-15
Brief Title:
Semaglutide 24mg for Low Responders After Bariatric Surgery
Sponsor:
Zuyderland Medisch Centrum
Organization:
Zuyderland Medisch Centrum
Study Overview
Official Title:
Semaglutide 24mg for Low Responders After Bariatric Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEABAR
Brief Summary:
In 20 - 30 of the patients the low responders sufficient weight loss is not achieved after bariatric surgery Secondary andor tertiary bariatric procedures can lead to successful weight loss and resolution of comorbid conditions though morbidity and mortality rates of these procedures are high Therefore additional pharmacotherapy has been suggested Semaglutide is one of the medications that might improve outcome in the post-bariatric population Semaglutide is a Glucagon-like peptide-1 GLP-1 receptor analogue developed to treat type 2 diabetes It causes glucose-dependent insulin secretion promotes satiety and inhibits glucagon secretion In obese non-bariatric patients semaglutide has shown to improve glycemic control decrease blood pressure lower cardiovascular risk and decrease body weight
Detailed Description:
The treatment of obesity can be divided into three different fields non-surgical interventions eg endoscopic techniques swallowable gastric balloon pharmacological and surgical treatment All these different fields have as their cornerstone of treatment lifestyle interventions Lifestyle interventions have an emphasis on regulation of energy intake and improvement of physical activity All treatment options are adjunct to the lifestyle interventions Besides not all overweight or obese people are eligible for all types of treatment For instance pharmacological treatment options are advised in patients with a Body Mass Index BMI 30kgm2 or a BMI 27kgm2 with an obesity-related comorbidity such as hypertension or diabetes mellitus Several pharmaceutical agents have been developed for treatment of obesity These medications generally affect appetite and cause weight loss only when the agent is taken in adjunct to lifestyle modification Mean weight loss with pharmacological treatment ranges between 44 and 143 depending on type of medication and treatment regime
Bariatric surgery also called metabolic surgery includes a variety of surgical procedures in which the gastro-intestinal tract is altered The most performed types of surgery are the Sleeve Gastrectomy SG and the Roux-en-Y gastric bypass RYGB All types of surgery cause changes in gut hormones bile acids and microbiota which subsequently induce changes in appetite and energy expenditure and thereby causing weight loss Surgery is generally advised to patients with a BMI 40kgm2 or a BMI 35kgm2 with comorbid conditions Compared to lifestyle intervention programs bariatric surgery has proven to be a superior treatment for morbid obesity Total weight loss TWL is about 20 - 30 In addition bariatric surgery positively influences comorbid conditions like type 2 diabetes hypertension cancer incidence cardiovascular events and cardiovascular deaths Thus currently bariatric surgery is the most effective treatment for morbid obesity
However there is a significant proportion of patients who do not reach successful weight loss after bariatric surgery These patients can be divided in patients who do not reach sufficient weight loss low responders and patients who experience weight regain Although there is no guideline to define who are low responders and what is significant weight regain unsuccessful weight loss seems to occur in about 20-30 of the population One of the best predictors of low weight loss in the long-term after surgery is 3-month weight loss Therefore this studys clinic provides an extra intervention for the patients who are considered low responders at the 3-month follow-up moment after surgery The NOK defines a low responder by percentage total weight loss TWL at the 3-month follow-up moment compared to expected weight loss When TWL is below the 25 quartile of expected weight loss the patient is considered a low responder The expected weight loss is determined based on this clinics database of previous patients with the same baseline Body Mass Index BMI above or below 50 kgm2 gender and type of surgery Thus in the current treatment program patients have a medical consultation in which weight loss is determined three months after surgery Based on baseline weight and exact number of days after surgery it is calculated whether the patient is a low responder with respect to a private database currently about 6000 patients If a patient is considered a low responder then the patient will receive three extra counselling sessions focusing on improving weight loss outcome This extra intervention is called the plus module and is an addition to the standard program which consists of multidisciplinary group counselling before and after surgery
Secondary andor tertiary bariatric procedures are performed in up to 25 of the patients with unsuccessful weight loss Although additional surgery can lead to successful weight loss and resolution of comorbid conditions morbidity and mortality rates of these procedures are higher Therefore attention has been focused on pharmacological treatment as an addition to bariatric surgery
One of the agents that has been suggested for additional pharmacological treatment is semaglutide Semaglutide is a Glucagon-like peptide-1 GLP-1 receptor analogue which was initially developed to treat type 2 diabetes GLP-1 is one of the incretins a peptide hormone which is normally secreted from L cells in the distal ileum and colon When secreted GLP-1 causes an increase in insulin secretion of the beta-cells of the pancreas and a decrease of glucagon production of the alfa-cells These changes cause a decrease of fasting and post prandial plasma glucose In addition GLP-1 also causes delayed gastric emptying In non-bariatric patients semaglutide has shown to improve glycaemic control decrease blood pressure lower cardiovascular risk and decrease body weight up to one year
In this trial the effect of semaglutide 24 mg once weekly to the plus module for low responders on the improvement of weight loss compared to patient solely receiving the plus module will be evaluated
Bariatric surgery also called metabolic surgery includes a variety of surgical procedures in which the gastro-intestinal tract is altered The most performed types of surgery are the Sleeve Gastrectomy SG and the Roux-en-Y gastric bypass RYGB All types of surgery cause changes in gut hormones bile acids and microbiota which subsequently induce changes in appetite and energy expenditure and thereby causing weight loss Surgery is generally advised to patients with a BMI 40kgm2 or a BMI 35kgm2 with comorbid conditions Compared to lifestyle intervention programs bariatric surgery has proven to be a superior treatment for morbid obesity Total weight loss TWL is about 20 - 30 In addition bariatric surgery positively influences comorbid conditions like type 2 diabetes hypertension cancer incidence cardiovascular events and cardiovascular deaths Thus currently bariatric surgery is the most effective treatment for morbid obesity
However there is a significant proportion of patients who do not reach successful weight loss after bariatric surgery These patients can be divided in patients who do not reach sufficient weight loss low responders and patients who experience weight regain Although there is no guideline to define who are low responders and what is significant weight regain unsuccessful weight loss seems to occur in about 20-30 of the population One of the best predictors of low weight loss in the long-term after surgery is 3-month weight loss Therefore this studys clinic provides an extra intervention for the patients who are considered low responders at the 3-month follow-up moment after surgery The NOK defines a low responder by percentage total weight loss TWL at the 3-month follow-up moment compared to expected weight loss When TWL is below the 25 quartile of expected weight loss the patient is considered a low responder The expected weight loss is determined based on this clinics database of previous patients with the same baseline Body Mass Index BMI above or below 50 kgm2 gender and type of surgery Thus in the current treatment program patients have a medical consultation in which weight loss is determined three months after surgery Based on baseline weight and exact number of days after surgery it is calculated whether the patient is a low responder with respect to a private database currently about 6000 patients If a patient is considered a low responder then the patient will receive three extra counselling sessions focusing on improving weight loss outcome This extra intervention is called the plus module and is an addition to the standard program which consists of multidisciplinary group counselling before and after surgery
Secondary andor tertiary bariatric procedures are performed in up to 25 of the patients with unsuccessful weight loss Although additional surgery can lead to successful weight loss and resolution of comorbid conditions morbidity and mortality rates of these procedures are higher Therefore attention has been focused on pharmacological treatment as an addition to bariatric surgery
One of the agents that has been suggested for additional pharmacological treatment is semaglutide Semaglutide is a Glucagon-like peptide-1 GLP-1 receptor analogue which was initially developed to treat type 2 diabetes GLP-1 is one of the incretins a peptide hormone which is normally secreted from L cells in the distal ileum and colon When secreted GLP-1 causes an increase in insulin secretion of the beta-cells of the pancreas and a decrease of glucagon production of the alfa-cells These changes cause a decrease of fasting and post prandial plasma glucose In addition GLP-1 also causes delayed gastric emptying In non-bariatric patients semaglutide has shown to improve glycaemic control decrease blood pressure lower cardiovascular risk and decrease body weight up to one year
In this trial the effect of semaglutide 24 mg once weekly to the plus module for low responders on the improvement of weight loss compared to patient solely receiving the plus module will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None