Ignite Creation Date:
2024-07-17 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501326
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-12-26
Brief Title:
Efficacy and Safety of Liraglutide in the Treatment of Obesity Combined With Metabolism Associated Fatty Liver Disease
Sponsor:
Affiliated Hospital of Nantong University
Organization:
Affiliated Hospital of Nantong University
Study Overview
Official Title:
Clinical Efficacy and Safety of Liraglutide in the Treatment of Obesity Combined With Metabolism-associated Fatty Liver Disease MAFLD
Status:
RECRUITING
Status Verified Date:
2023-11
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:
None
Brief Summary:
STUDY OBJECTIVE To explore the clinical efficacy and safety of liraglutide in obesity combined with metabolism-associated fatty liver disease MAFLD
INTERVENTION PROGRAM All subjects underwent dietary control and exercise therapy and controlled smoking and alcohol consumption During the 3 months of the trial men were instructed to follow a diet of 1500 to 1800 kcal per day and women followed a diet of 1200 to 1500 kcal per day All three diets included 40 to 55 percent carbohydrates 15 to 20 percent protein and 20 to 30 percent fat During the 3-month trial period subjects performed at least 150 minutes of moderate-intensity exercise per week with an energy expenditure of 1500 kcalweek or more Other medications containing the same ingredients as orlistat and liraglutide were prohibited during the trial period After randomization the control group was treated with lifestyle intervention orlistat until the end of follow-up Trial group 1 was treated with lifestyle intervention liraglutide Trial group 2 was treated with lifestyle intervention liraglutide orlistat for a total treatment and follow-up period of 3 months
INTERVENTION PROGRAM All subjects underwent dietary control and exercise therapy and controlled smoking and alcohol consumption During the 3 months of the trial men were instructed to follow a diet of 1500 to 1800 kcal per day and women followed a diet of 1200 to 1500 kcal per day All three diets included 40 to 55 percent carbohydrates 15 to 20 percent protein and 20 to 30 percent fat During the 3-month trial period subjects performed at least 150 minutes of moderate-intensity exercise per week with an energy expenditure of 1500 kcalweek or more Other medications containing the same ingredients as orlistat and liraglutide were prohibited during the trial period After randomization the control group was treated with lifestyle intervention orlistat until the end of follow-up Trial group 1 was treated with lifestyle intervention liraglutide Trial group 2 was treated with lifestyle intervention liraglutide orlistat for a total treatment and follow-up period of 3 months
Detailed Description:
1 Randomization Patients were divided into three groups by lifestyle intervention orlistat treatment in lifestyle intervention liraglutide treatment and in lifestyle intervention orlistat liraglutide treatment and eligible patients were randomized into trial group 12 and control group strictly according to the random number method The ratio of test group 12 and control group was 111
2 Name and specification of the intervention study medication Use liraglutide injection 3ml 18mg prefilled pen and orlistat capsules
3 Study the intervention program All subjects were treated with dietary control and exercise therapy and controlled smoking and alcohol consumptionDuring the 3 months of the trial men were instructed to follow a diet of 1500 to 1800 kcal per day and women followed a diet of 1200 to 1500 kcal per day All three groups of diets included 40 to 55 carbohydrates 15 to 20 protein and 20 to 30 fatDuring the 3-month trial period conduct at least 150 minutes of moderate intensity exercise per week with exercise energy consumption of 1500 kcal week or moreOther drugs containing the same ingredients of orlistat and liraglutide were prohibited during the trialAfter randomization the control group was treated with lifestyle intervention orlistat until the end of follow-upTrial Group 1 was treated with lifestyle intervention plus liraglutideTrial Group 2 was treated with lifestyle intervention plus liraglutide plus orlistatMedication regimen Patients in the test or control groups were treated with liraglutide or and orlistat for 3 months from the first day after enrollment The starting dose of liraglutide was 06mg per day gradually increased to 12mg per day after one week and continued to 18mg per day when tolerated Patients taking orlistat should take 120mg orlistat capsules every day or one hour after a meal and if one meal is not eaten or the food is not fat they can be omitted
4 Efficacy evaluation index primary efficacy index and secondary efficacy index glycosylated hemoglobin FABP 4 body weight waist circumference hip circumference BMI and lipid index TC TG HDL-C LDL-C Liver fibrosis index liver hardness liver fat attenuation fibro scan detection instrument body fat volume visceral fat area inbody body meter liver function index balanced and comparable analysis of ALT and AST before the treatment of the three groups of 1 2 the change of each level before and after treatment Test of their respective efficacy 3 The difference between the three groups after treatment and the difference between the groups and the three groups
2 Name and specification of the intervention study medication Use liraglutide injection 3ml 18mg prefilled pen and orlistat capsules
3 Study the intervention program All subjects were treated with dietary control and exercise therapy and controlled smoking and alcohol consumptionDuring the 3 months of the trial men were instructed to follow a diet of 1500 to 1800 kcal per day and women followed a diet of 1200 to 1500 kcal per day All three groups of diets included 40 to 55 carbohydrates 15 to 20 protein and 20 to 30 fatDuring the 3-month trial period conduct at least 150 minutes of moderate intensity exercise per week with exercise energy consumption of 1500 kcal week or moreOther drugs containing the same ingredients of orlistat and liraglutide were prohibited during the trialAfter randomization the control group was treated with lifestyle intervention orlistat until the end of follow-upTrial Group 1 was treated with lifestyle intervention plus liraglutideTrial Group 2 was treated with lifestyle intervention plus liraglutide plus orlistatMedication regimen Patients in the test or control groups were treated with liraglutide or and orlistat for 3 months from the first day after enrollment The starting dose of liraglutide was 06mg per day gradually increased to 12mg per day after one week and continued to 18mg per day when tolerated Patients taking orlistat should take 120mg orlistat capsules every day or one hour after a meal and if one meal is not eaten or the food is not fat they can be omitted
4 Efficacy evaluation index primary efficacy index and secondary efficacy index glycosylated hemoglobin FABP 4 body weight waist circumference hip circumference BMI and lipid index TC TG HDL-C LDL-C Liver fibrosis index liver hardness liver fat attenuation fibro scan detection instrument body fat volume visceral fat area inbody body meter liver function index balanced and comparable analysis of ALT and AST before the treatment of the three groups of 1 2 the change of each level before and after treatment Test of their respective efficacy 3 The difference between the three groups after treatment and the difference between the groups and the three groups
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?:
False
Is an FDA AA801 Violation?:
None