ChiCTR2100050042
正在进行
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2021-08-16
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Non-alcoholic fatty liver disease
Ketogenic diet for non-alcoholic fatty liver disease in obese adolescents: a randomized controlled trial
Ketogenic diet for non-alcoholic fatty liver disease in obese adolescents: a randomized controlled trial
1. To examine whether intrahepatic fat content in obese adolescents with non-alcoholic fatty liver disease will decrease with adoption of a ketogenic diet program comparatively to the previously evaluated lifestyle modification program. 2. To determine the effectiveness on sustainability of both interventions of the ketogenic diet program and lifestyle modification program for 52 weeks. 3. To assess any impact of these interventions on the microbiomes of obese adolescents.
随机平行对照
其它
Subjects will be randomly assigned to either Group 1 (KDP) or Group 2 (LMP) on 1:1 ratio using computer generated random numbers. A study Research Assistant not involved with other follow-ups will use statistical software R to randomly generate the intervention allocation.
Once the intervention has been allocated, the research staff will not be blinded to participants group assignment.
Health and Medical Research Fund (HMRF)
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45
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2021-09-01
2024-08-31
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1. Post-pubertal Chinese adolescents aged 14-18 years with primary obesity attending the Obesity and Lipid Disorder Clinic in PWH (with a visit within the previous year and/or with severe obesity at last visit) and potentially from the endocrine clinics of other Hospital Authority (HA) hospitals. 2. Can read Chinese. 3. Signed informed consent by parents and assent by children. 4. Obese adolescents with suspected NAFLD based on previous ultrasound examination or raised liver enzymes.；
登录查看1. Patients with Type II diabetes. 2. Patients with Prader Willi Syndrome. 3. Hepatic viral infection. 4. Daily usage of alcohol, from parental or self-report. 5. BMI below 95th centile of local reference. 6. Using steatogenic and/or anti-diabetic drugs. 7. Concurrent participation in any clinical trial, dietary intervention or weight loss program. 8. Concomitant intake of a weight reducing agent. 9. Any chronic medical illness requiring long term regular medical treatment but to exclude common allergic conditions such as asthma, eczema and allergic rhinitis. 10. Unwillingness to attend regular follow up appointments as part of the intervention program.；
登录查看Nil
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药明康德2024-10-25
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瑞博小核酸2024-10-24
君实医学2024-10-24
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