Condition: Type 2 Diabetes Mellitus (T2DM) · Mild Cognitive Impairment (MCI) · Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
A single-center, prospective, open-label, parallel-group randomized controlled trial is conducted to investigate the cognitive-protective efficacy of a novel, diabetes-specific virtual reality (VR)-based cognitive training system integrated with diet management modules, relative to frequency- and duration-matched traditional paper-and-pencil cognitive training, in adults aged 45-80 years with T2DM and amnestic/mixed mild cognitive impairment (MCI). A total of 40 eligible participants are randomly assigned 1:1 to either the intervention group (16 weeks of individualized VR training with dynamic difficulty, 2 sessions/week, 30-60 minutes/session) or the active control group (standardized paper-and-pencil cognitive tasks). All participants maintain stable glucose-lowering regimens for ≥3 months and receive standardized weekly diabetes health education. The primary endpoint is the between-group difference in the change in MoCA total score from baseline to the 16-week follow-up. Secondary endpoints include changes in individual cognitive domains (memory, executive function, attention, processing speed), olfactory threshold/identification/recall, brain structural volumes and resting-state functional connectivity (assessed via 3.0T fMRI), glycemic control (HbA1c, fasting/postprandial glucose), lipid profile, body composition, sleep quality, anxiety and depressive symptoms, and diabetes self-management behaviors. The safety and participant adherence to the VR intervention are also sy…
This description comes directly from the study's public registry record.
Yan Bi, MD, PhD · 6-25-83-105302 · biyan@nju.edu.cn
Zhou Zhang, MD, PhD · (86) 25-83106666 · zhangzhou@smail.nju.edu.cn
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| Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School | Nanjing, Jiangsu, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07650318