背景:全球糖尿病发病率上升,尤其是在印度,构成了重大的公共卫生挑战,由于意识有限等因素,财务压力,以及阻碍其有效管理的文化因素。尽管生活方式的改变已经显示出有希望的结果,它们的一致实施和维护继续构成挑战。大多数研究主要集中在饮食调整上,忽略生活方式干预的其他重要方面。DiRemi研究旨在通过评估综合饮食的为期一年的计划的有效性来解决这些差距,锻炼,心理支持,和医疗管理来实现减肥,糖尿病缓解,并改善了印度2型糖尿病(T2D)患者的血糖控制,同时也考虑到印度人口的独特需求。
方法:DiRemi研究是一项前瞻性研究,开放标签,配对组试验旨在评估包括饮食调整在内的为期一年的在线综合强化生活方式干预(ILI)的影响,身体活动,心理支持,以及成人T2D患者(30-70岁)体重减轻和缓解的医疗管理,体重指数(BMI)在25至35kg/m2之间,疾病持续时间<15年。ILI将与常规医疗(RMC)进行比较。参与者将从三个诊所招募:一个提供ILI,另外两个提供RMC。共同的主要结果将是12个月时的体重减轻和缓解,随访18个月。建议的样本量为360名参与者(干预组和对照组各180名)。
结论:DiRemi研究代表了印度首个大规模缓解研究,显示综合治疗方法在T2D及其并发症的缓解和管理中的有效性。这项研究的结果有可能报告印度和全球管理T2D的循证策略,从而减轻糖尿病对公共卫生系统的沉重负担。
背景:临床试验注册,印度(注册号:CTRI/2023/06/053885)。
BACKGROUND: The global rise in diabetes, particularly in
India, poses a significant public health challenge, with factors such as limited awareness, financial strain, and cultural considerations hindering its effective management. Although lifestyle changes have shown promising results, their consistent implementation and maintenance continue to pose challenges. Most studies have focused primarily on dietary modifications, overlooking other essential aspects of lifestyle intervention. The DiRemI study aims to address these gaps by evaluating the efficacy of a comprehensive one-year program that combines diet, exercise, psychological support, and medical management to achieve weight loss, diabetes remission, and improved glycemic control among patients with type 2 diabetes (T2D) in
India, while also considering the unique needs of the Indian population.
METHODS: The DiRemI study is a prospective, open-label, matched-group trial aimed at assessing the impact of a one-year online integrated intensive lifestyle intervention (ILI) comprising dietary modifications, physical activity, psychological support, and medical management on weight loss and remission in adult T2D patients (aged 30-70 years), with a body mass index (BMI) between 25 and 35 kg/m2, and disease duration of <15 years. ILI will be compared with routine medical care (RMC). Participants will be recruited from three clinics: one providing ILI and two others providing RMC. The co-primary outcome will be weight loss and remission at 12 months, with a follow-up at 18 months. The proposed sample size is 360 participants (180 each in intervention and control group).
CONCLUSIONS: The DiRemI study represents the first large-scale remission study in
India to show the effectiveness of an integrated approach in the remission and management of T2D and its complications. The findings of this study hold the potential to report evidence-based strategies for managing T2D both in
India and globally, thus alleviating the substantial burden of diabetes on public health systems.
BACKGROUND: Clinical Trials Registry,
India (Registered Number: CTRI/2023/06/053885).