Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546384
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
GLP-1 RA on Alcohol Consumption Metabolism and Liver Parameters in Patients With Obesity and Fatty Liver Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Glucagon-like Peptide-1 Receptor Agonists GLP-1 RA on Alcohol Consumption Metabolism and Liver Parameters in Patients With Obesity and Fatty Liver Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
GLP-1 RA
Brief Summary:
There is evidence that alcoholic beverage consumption significantly interacts with food energy intake Furthermore there is accumulating evidence showing independent combined and modifying effects of alcohol and metabolic factors on the onset and progression of chronic liver disease Preclinical and clinical data have showed that GLP-1 RA can decrease alcohol consumption particularly in obese patients Moreover there is evidence that liraglutide can improve the liver sinusoidal milieu in pre-clinical models of cirrhosis
In this study the investigators aim to assess if patients treated with liraglutide and receiving counselling will achieve a significantly higher alcohol abstinence compared to patients only receiving counselling
In this study the investigators aim to assess if patients treated with liraglutide and receiving counselling will achieve a significantly higher alcohol abstinence compared to patients only receiving counselling
Detailed Description:
In Switzerland approximately 20 of the population is consuming more alcohol than recommended by the WHO There is evidence that alcoholic beverage consumption significantly interacts with food energy intake Although several studies have investigated the role of alcohol in obesity there is still a lack of knowledge about specific roles of different types of alcoholic beverages and on the effect of consumption patterns in patients with metabolic syndrome and obesity Nevertheless there is accumulating evidence showing independent combined and modifying effects of alcohol and metabolic factors on the onset and progression of chronic liver disease
Glucagon-like peptide-1 GLP-1-based therapy for type 2 diabetes was introduced in 2006 GLP-1 is an incretin hormone which is secreted from endocrine L cells of the small intestine in response to nutrients in the gut lumen Exendin-4 binds to the GLP-1R with high affinity and acts as a receptor agonist thus referred to as GLP-1 receptor agonists GLP-1 RA To date the GLP-1 RA dulaglutide liraglutide semaglutide lixisenatide and exenatide are approved for the treatment of diabetes mellitus type II in Switzerland Since 2020 the GLP-1 RA liraglutide is also approved for the treatment of obesity in Switzerland GLP-1 RA have a well-established effect on the food reward system which is regulated by key mesolimbic brain regions the ventral tegmental area VTA and nucleus accumbens NAc11 Interestingly these regions are also involved in the rewarding effects of drugs of abuse and alcohol A link between alcohol intake and GLP-1 has been demonstrated in several preclinical studies and may play an important role in the development of addiction The findings are consistent with the hypothesis that systemic administration of GLP-1 RA can influence the mesolimbic dopamine system and reward-seeking behaviours associated with alcohol use disorder AUD Furthermore preclinical data has shown that GLP-1 RA namely liraglutide significantly improved liver microvascular function and exhibited anti-fibrotic effects of confirmed in human liver tissue
In metabolic fatty liver disease GLP-1 RA have a significant effect on reducing steatosis and inflammation Obesity is one of the main risk factors for fatty liver disease particularly central adiposity and one of the leading drivers for liver disease progression independent of the cause of liver disease In a Swiss referral liver centre 75 of patients with advanced cirrhosis have either alcohol metabolic or combined factors 25 as the cause for liver disease Therapeutic strategies approaching both aetiologies are thus urgently needed
The investigators aim to investigate in this study whether there is a significant beneficial effect of GLP-1 RA specifically liraglutide on alcohol consumption specifically in obese patients Furthermore the investigators aim to systematically assess drinking patterns and alcohol beverage consumption in patients with obesity assessed with the innovative direct alcohol biomarker phosphatidylethanol PEth24 that overcomes the problems of low reliability of medical history standard questionnaires and previous tests in assessing recent alcohol consumption
Glucagon-like peptide-1 GLP-1-based therapy for type 2 diabetes was introduced in 2006 GLP-1 is an incretin hormone which is secreted from endocrine L cells of the small intestine in response to nutrients in the gut lumen Exendin-4 binds to the GLP-1R with high affinity and acts as a receptor agonist thus referred to as GLP-1 receptor agonists GLP-1 RA To date the GLP-1 RA dulaglutide liraglutide semaglutide lixisenatide and exenatide are approved for the treatment of diabetes mellitus type II in Switzerland Since 2020 the GLP-1 RA liraglutide is also approved for the treatment of obesity in Switzerland GLP-1 RA have a well-established effect on the food reward system which is regulated by key mesolimbic brain regions the ventral tegmental area VTA and nucleus accumbens NAc11 Interestingly these regions are also involved in the rewarding effects of drugs of abuse and alcohol A link between alcohol intake and GLP-1 has been demonstrated in several preclinical studies and may play an important role in the development of addiction The findings are consistent with the hypothesis that systemic administration of GLP-1 RA can influence the mesolimbic dopamine system and reward-seeking behaviours associated with alcohol use disorder AUD Furthermore preclinical data has shown that GLP-1 RA namely liraglutide significantly improved liver microvascular function and exhibited anti-fibrotic effects of confirmed in human liver tissue
In metabolic fatty liver disease GLP-1 RA have a significant effect on reducing steatosis and inflammation Obesity is one of the main risk factors for fatty liver disease particularly central adiposity and one of the leading drivers for liver disease progression independent of the cause of liver disease In a Swiss referral liver centre 75 of patients with advanced cirrhosis have either alcohol metabolic or combined factors 25 as the cause for liver disease Therapeutic strategies approaching both aetiologies are thus urgently needed
The investigators aim to investigate in this study whether there is a significant beneficial effect of GLP-1 RA specifically liraglutide on alcohol consumption specifically in obese patients Furthermore the investigators aim to systematically assess drinking patterns and alcohol beverage consumption in patients with obesity assessed with the innovative direct alcohol biomarker phosphatidylethanol PEth24 that overcomes the problems of low reliability of medical history standard questionnaires and previous tests in assessing recent alcohol consumption
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