Sugimoto Taiki, Araki Atsushi, Fujita Hiroki, Honda Keiko, Inagaki Nobuya, Ishida Takeshi, Kato Junichi, Kishi Minoru, Kobayashi Kazuki, Kouyama Kunichi, Noma Hisashi, Ohishi Mitsuru, Satoh-Asahara Noriko, Shimada Hiroyuki, Sugimoto Kazuhiro, Suzuki Susumu, Takeya Yasushi, Tamura Yoshiaki, Tokuda Haruhiko, Umegaki Hiroyuki, Watada Hirotaka, Yamada Yuichiro, Sakurai Takashi
Center for Comprehensive Care and Research on Memory Disorders, National Center for Geriatrics and Gerontology, Obu, Japan.
Medical Genome Center, National Center for Geriatrics and Gerontology, Obu, Japan.
Front Aging Neurosci. 2021 Jul 12;13:680341. doi: 10.3389/fnagi.2021.680341. eCollection 2021.
The Japan-Multi-domain Intervention Trial for Prevention of Dementia in Older Adults with Diabetes (J-MIND-Diabetes) is an 18-month, multi-centered, open-labeled, randomized controlled trial designed to identify whether multi-domain intervention targeting modifiable risk factors for dementia could prevent the progression of cognitive decline among older adults with type 2 diabetes mellitus (T2DM). This manuscript describes the study protocol for the J-MIND-Diabetes trial. Subjects of this trial will comprise a total of 300 T2DM outpatients aged 70-85 years with mild cognitive impairment. Subjects will be centrally randomized into intervention and control groups at a 1:1 allocation ratio using the stratified permuted-block randomization methods. The intervention group will participate in multi-domain intervention programs aimed at: (1) management of metabolic and vascular risk factors; (2) physical exercise and self-monitoring of physical activity; (3) nutritional guidance; and (4) social participation. The control group will receive usual T2DM care and general instructions on dementia prevention. The primary and secondary outcomes will be assessed at baseline, at 6- and 18-month follow-up. The primary outcome is change from baseline at 18 months in a global composite score combining several neuropsychological domains, including global cognitive function, memory, attention, executive function, processing speed and language. Secondary outcomes include: (1) cognitive changes in neuropsychological tests; (2) changes in geriatrics assessments; (3) metabolic control and diabetic complications; (4) changes in blood and urinary markers. This trial will be the first trial to demonstrate the effectiveness of multi-domain intervention in preventing cognitive decline in older adults with T2DM at increased risk of dementia in Japan. UMIN000035911; Registered on the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) 18 February 2019. (https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040908).
日本老年糖尿病患者痴呆预防多领域干预试验（J-MIND-Diabetes）是一项为期18个月的多中心、开放标签随机对照试验，旨在确定针对痴呆可改变风险因素的多领域干预是否能预防2型糖尿病（T2DM）老年患者认知功能衰退的进展。本手稿描述了J-MIND-Diabetes试验的研究方案。该试验的受试者将总共包括300名年龄在70至85岁之间、患有轻度认知障碍的T2DM门诊患者。受试者将使用分层排列块随机化方法按1:1的分配比例集中随机分为干预组和对照组。干预组将参与旨在：（1）管理代谢和血管危险因素；（2）体育锻炼和身体活动自我监测；（3）营养指导；（4）社会参与的多领域干预计划。对照组将接受常规T2DM护理和痴呆预防的一般指导。主要和次要结局将在基线、6个月和18个月随访时进行评估。主要结局是在18个月时，综合多个神经心理领域（包括整体认知功能、记忆、注意力、执行功能、处理速度和语言）的全球综合评分相对于基线的变化。次要结局包括：（1）神经心理测试中的认知变化；（2）老年评估的变化；（3）代谢控制和糖尿病并发症；（4）血液和尿液标志物的变化。 本试验将是日本首个证明多领域干预对预防痴呆风险增加的T2DM老年患者认知衰退有效性的试验。UMIN000035911；于2019年2月18日在大学医院医学信息网络临床试验注册中心（UMIN-CTR）注册。（https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040908）
