PDF(Pubmed)
Abstract：
BACKGROUND: Diabetes and depression are among the 10 biggest health burdens globally. They often coexist and exhibit a strong bidirectional relationship. Depression leads to decreased adherence to self-care activities. This impacts glycaemic control and worsens type 2 diabetes mellitus (T2D). Both conditions have a synergistic effect and lead to greater complications, hospitalisations, healthcare expenditure and a worse quality of life. There is no consensus on managing people with comorbid T2D and depression. Bupropion is an efficacious antidepressant with many properties suitable for T2D with depression, including a favourable metabolic profile, persistent weight loss and improvement in sexual dysfunction. We will assess the efficacy and safety of add-on bupropion compared with standard care in people with T2D and mild depression. This study can give valuable insights into managing the multimorbidity of T2D and depression. This can help mitigate the health, social and economic burden of both these diseases.
METHODS: This cross-over randomised controlled trial will recruit people with T2D (for 5 years or more) with mild depression. They will be randomised to add-on bupropion and standard care. After 3 months of treatment, there will be a washout period of 1 month (without add-on bupropion while standard treatment will continue). Following this, the two arms will be swapped. Participants will be assessed for glycosylated haemoglobin, adherence to diabetes self-care activities, lipid profile, urine albumin-to-creatinine ratio, autonomic function, sexual function, quality of life and adverse events.
BACKGROUND: The Institutional Ethics Committee at All India Institute of Medical Sciences, Jodhpur has approved this study (AIIMS/IEC/2022/4172, 19 September 2022). We plan to disseminate the research findings via closed group discussions at the site of study, scientific conferences, peer-reviewed published manuscripts and social media.
BACKGROUND: CTRI/2022/10/046411.
METHODS: This cross-over randomised controlled trial will recruit people with T2D (for 5 years or more) with mild depression. They will be randomised to add-on bupropion and standard care. After 3 months of treatment, there will be a washout period of 1 month (without add-on bupropion while standard treatment will continue). Following this, the two arms will be swapped. Participants will be assessed for glycosylated haemoglobin, adherence to diabetes self-care activities, lipid profile, urine albumin-to-creatinine ratio, autonomic function, sexual function, quality of life and adverse events.
BACKGROUND: The Institutional Ethics Committee at All India Institute of Medical Sciences, Jodhpur has approved this study (AIIMS/IEC/2022/4172, 19 September 2022). We plan to disseminate the research findings via closed group discussions at the site of study, scientific conferences, peer-reviewed published manuscripts and social media.
BACKGROUND: CTRI/2022/10/046411.
摘要：
背景：糖尿病和抑郁症是全球十大健康负担之一。它们经常共存并表现出强烈的双向关系。抑郁症导致对自我护理活动的依从性下降。这会影响血糖控制并恶化2型糖尿病（T2D）。两种情况都有协同作用，并导致更大的并发症，住院治疗,医疗支出和更差的生活质量。在管理患有T2D和抑郁症的人方面没有共识。安非他酮是一种有效的抗抑郁药，具有许多适用于患有抑郁症的T2D的特性，包括良好的代谢特征，持续的体重减轻和性功能障碍的改善。我们将评估附加安非他酮的疗效和安全性与T2D和轻度抑郁症患者的标准治疗相比。这项研究可以为管理T2D和抑郁症的多发病率提供有价值的见解。这可以帮助减轻健康，这两种疾病的社会和经济负担。
方法：这项交叉随机对照试验将招募患有T2D（5年或更长时间）的轻度抑郁症患者。他们将被随机分配给安非他酮和标准护理。治疗3个月后,将有1个月的冲洗期（不添加安非他酮，而标准治疗将继续）。在此之后,这两个手臂将被交换。参与者将被评估为糖化血红蛋白，坚持糖尿病自我护理活动，血脂谱,尿白蛋白与肌酐的比值,自主神经功能,性功能,生活质量和不良事件。
背景：全印度医学科学研究所的机构伦理委员会，焦特布尔已批准本研究（AIIMS/IEC/2022/4172，2022年9月19日）。我们计划在研究现场通过封闭的小组讨论传播研究结果，科学会议,同行评审出版的手稿和社交媒体。
背景：CTRI/2022/10/046411。
方法：这项交叉随机对照试验将招募患有T2D（5年或更长时间）的轻度抑郁症患者。他们将被随机分配给安非他酮和标准护理。治疗3个月后,将有1个月的冲洗期（不添加安非他酮，而标准治疗将继续）。在此之后,这两个手臂将被交换。参与者将被评估为糖化血红蛋白，坚持糖尿病自我护理活动，血脂谱,尿白蛋白与肌酐的比值,自主神经功能,性功能,生活质量和不良事件。
背景：全印度医学科学研究所的机构伦理委员会，焦特布尔已批准本研究（AIIMS/IEC/2022/4172，2022年9月19日）。我们计划在研究现场通过封闭的小组讨论传播研究结果，科学会议,同行评审出版的手稿和社交媒体。
背景：CTRI/2022/10/046411。
