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        【ChiCTR2100050042】Ketogenic diet for non-alcoholic fatty liver disease in obese adolescents: a randomized controlled trial

        基本信息
        登记号

        ChiCTR2100050042

        试验状态

        正在进行

        药物名称

        /

        药物类型

        /

        规范名称

        /

        首次公示信息日的期

        2021-08-16

        临床申请受理号

        /

        靶点

        /

        适应症

        Non-alcoholic fatty liver disease

        试验通俗题目

        Ketogenic diet for non-alcoholic fatty liver disease in obese adolescents: a randomized controlled trial

        试验专业题目

        Ketogenic diet for non-alcoholic fatty liver disease in obese adolescents: a randomized controlled trial

        申办单位信息
        申请人联系人
        申请人名称
        联系人邮箱
        联系人邮编

        联系人通讯地址
        临床试验信息
        试验目的

        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.

        试验分类
        试验类型

        随机平行对照

        试验分期

        其它

        随机化

        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.

        盲法

        Once the intervention has been allocated, the research staff will not be blinded to participants group assignment.

        试验项目经费来源

        Health and Medical Research Fund (HMRF)

        试验范围

        /

        目标入组人数

        45

        实际入组人数

        /

        第一例入组时间

        2021-09-01

        试验终止时间

        2024-08-31

        是否属于一致性

        /

        入选标准

        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.；

        排除标准

        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.；

        研究者信息
        研究负责人姓名
        试验机构

        Nil

        研究负责人电话
        研究负责人邮箱
        研究负责人邮编

        /

        联系人通讯地址

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