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| ID | Type | Description | Link |
|---|---|---|---|
| 2023ZD0508704 | Other Grant/Funding Number | Noncommunicable Chronic Diseases-National Science and Technology Major Project |
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Cirrhosis associated with metabolic associated fatty liver disease (MAFLD) can lead to a series of adverse outcomes in and outside the liver, but there is no approved treatment so far. In recent years, the prevalence of MAFLD-related cirrhosis in our country is increasing rapidly, but its clinical, pathological characteristics and natural prognosis are not clear, and there is a lack of standardized and effective prevention and treatment strategies.Through"Digital Intelligence software" to assist clinicians in MAFLD patients with remote data intervention, lifestyle intervention guidance and follow-up management, to evaluate the efficacy and safety of the intervention software on body weight and blood glucose in patients with MAFLD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Life intervention group | No Intervention | Detailed nutritional intervention protocols were developed according to patients' food preferences, dietary habits, physical activity levels, working conditions, sociocultural conditions, and lifestyle. Low-carbon diet and balanced diet were adopted for dietary intervention. According to the patients' basic metabolic level, overweight and fatty liver degree, a calorie restriction diet was formulated, and it was recommended to reduce 500-1000 kcal calories per day, a balanced diet of pastries and carbohydrates, with increased intake of whole grains, omega-3 fatty acid, and dietary fiber. Choose the right ingredients for your particular patient's diet | |
| Digital Intelligence Software Group | Placebo Comparator | Study participants were guided by the program officer to download and register the"Data Intelligence software (patient-side)" and to establish a relationship with the clinicians involved in the study, baseline data were collected under the guidance of the program director, health records were created, and data were collected using a software-supported"Body composition analyzer.". The participating clinicians evaluated the subjects through the"Digital Intelligence software (doctor side)", and formulated the diet and exercise program according to the individual conditions of the subjects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Intelligence Software Intervention Group | Procedure | Study participants were guided by the program officer to download and register the"Data Intelligence software (patient-side)" and to establish a relationship with the clinicians involved in the study, baseline data were collected under the guidance of the program director, health records were created, and data were collected using a software-supported"Body composition analyzer.". The participating clinicians evaluated the subjects through the"Digital Intelligence software (doctor side)", and formulated the diet and exercise program according to the individual conditions of the subjects. |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Absolute and relative changes from baseline in body weight | 48weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting plasma glucose | Compare the changes in fasting blood glucose before and after treatment | 48week |
| Liver MRI PDFF | To evaluate the effects of weight and glucose reduction interventions on proton density fat fraction (MRI-PDFF) in patients with MAFLD |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical indicators | Serum levels of aspartate aminotransferase (AST U/L) and alanine aminotransferase (ALT U/L) | 48week |
Inclusion Criteria
Exclusion Criteria
Pregnancy or lactation.
1.Any other condition or circumstance that, in the opinion of the Investigator, would compromise patient safety or the validity of the study data.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| junping shi, doctor's degree | Contact | +86 139 5712 1199 | 20131004@hznu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou Normal University Hospital | Recruiting | Hangzhou | Zhejiang | China |
The study has not been completed
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| 48weeks |
| Liver FibroScan | liver fat attenuation parameter (CAP) , liver stiffness value (LSM) | 48week |
| Body Mass Index (BMI) | Clarify how multiple measurements will be aggregated to arrive at one reported value weight and height will be combined to report BMI in kg/m^2) | 48week |