Department of Research, Freedom From Diabetes Research Foundation, Pune, Maharashtra, India.
Department of Management & Exercise Science, Freedom from Diabetes Clinic, Pune, Maharashtra, India.
PLoS One. 2024 Jun 28;19(6):e0306394. doi: 10.1371/journal.pone.0306394. eCollection 2024.
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). DISCUSSION: 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. TRIAL REGISTRATION: Clinical Trials Registry, India (Registered Number: CTRI/2023/06/053885).
背景:糖尿病在全球范围内的发病率不断上升,特别是在印度,这对公共卫生构成了重大挑战。由于缺乏意识、经济压力和文化因素等多种因素的影响,糖尿病的有效管理面临困难。尽管生活方式的改变已显示出良好的效果,但要使其持续实施和维持仍存在挑战。大多数研究主要集中在饮食改变上,而忽略了生活方式干预的其他重要方面。DiRemI 研究旨在通过评估一项为期一年的综合计划的效果来解决这些差距,该计划结合了饮食、运动、心理支持和医疗管理,以帮助印度的 2 型糖尿病(T2D)患者实现减肥、糖尿病缓解和改善血糖控制,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、开放标签、配对组试验,旨在评估为期一年的在线综合强化生活方式干预(ILI)对体重减轻和 T2D 成年患者缓解的影响(年龄在 30-70 岁之间,BMI 为 25-35kg/m2,疾病持续时间<15 年)。ILI 将与常规医疗护理(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。主要复合结局将是 12 个月时的体重减轻和缓解,随访时间为 18 个月。拟招募的样本量为 360 名参与者(干预组和对照组各 180 名)。
讨论:DiRemI 研究是印度首例大型缓解研究,旨在展示综合方法在 T2D 缓解和管理及其并发症方面的有效性。该研究的结果有可能为印度和全球的 T2D 管理提供循证策略,从而减轻糖尿病对公共卫生系统的巨大负担。
试验注册:印度临床试验注册处(注册号:CTRI/2023/06/053885)。
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