A Feasibility Study of an APN-Led Intensive Individualized Lifestyle Modification Program on Body Composition and Metabolic Control Among Adults with Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Faculty of Medicine Ramathibodi Hospital, Mahidol University0 个研究点目标入组 45 人开始时间: 2025年1月15日最近更新: 2026年8月3日

适应症

试验速览

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•Aged 18 to 60 years,
•Diagnosed with type 2 diabetes mellitus,
•Body mass index (BMI) of 23 kg/m2 or higher,
•Diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD) confirmed by FibroScan (controlled attenuation parameter 215 dB/m or higher) or liver ultrasonography,
•Able to read and understand the Thai language,
•Own and are able to use a smartphone for telehealth communication and self-monitoring,
•In the Preparation stage of behavior change,
•Willing to participate, provide written informed consent, and comply with all study procedures.

•Excessive alcohol consumption (more than 420 g per week for men or more than 350 g per week for women,
•History of malignancy or decompensated liver cirrhosis,
•Heart failure or acute coronary syndrome,
•Chronic kidney disease stage 4 or higher,
•Pregnant or breastfeeding women,
•Currently participating in another lifestyle intervention or weight management program,
•Currently receiving weight-loss medications or dietary supplements intended for weight reduction,
•Presence of a pacemaker or implanted metallic device that may interfere with body composition measurement by bioelectrical impedance analysis,
•Any medical or psychological condition that, in the opinion of the investigator, may interfere with study participation, adherence to the intervention, or completion of the study.

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