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| Name | Class |
|---|---|
| Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | INDUSTRY |
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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 1,500 to 1,800 kcal per day and women followed a diet of 1,200 to 1,500 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 kcal/week 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lifestyle intervention + orlistat group | Active Comparator | The control group was treated with lifestyle intervention + orlistat until the end of follow-up. |
|
| lifestyle intervention + liraglutide group | Experimental | Trial group 1 was treated with lifestyle intervention + liraglutide. |
|
| lifestyle intervention + liraglutide + orlistat group | Experimental | Trial group 2 was treated with lifestyle intervention + liraglutide + orlistat for a total treatment and follow-up period of 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Body weight | Three months |
| FABP4 | fatty acid-binding protein-4 | Three months |
| BMI | body mass index | Three months |
| lipid indices | TC, TG, HDL-C, LDL-C | Three months |
| LSM | liver stiffness measurement | Three months |
| CAP | Controlled attenuation parameters | Three months |
| Measure | Description | Time Frame |
|---|---|---|
| Waist circumference, | Waist circumference | Three months |
| hip circumference | hip circumference | Three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GU Yunjuan, doctor | Contact | 15851207860 | 86 | desette@ntu.edu.cn |
| XIA Jie, master | Contact | 19502555209 | 86 | desette@ntu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| GU Yunjuan, doctor | Affiliated Hospital of Nantong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Nantong University | Recruiting | Nantong | Jiangsu | China |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D050177 | Overweight |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D000077403 | Orlistat |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| Orlistat | Drug | 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. |
|
| D044343 |
| Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D007783 | Lactones |
| D009930 | Organic Chemicals |