Fan Xuechun, Wang Yanyan, Cao Jingsi, Yu Jing, Tian Jiaxing, Mi Jia
College of Traditional Chinese Medicine, Changchun University of Chinese Medicine, Changchun, Jilin, China.
Department of Endocrinology, The Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, Jilin, China.
Front Endocrinol (Lausanne). 2025 Apr 9;16:1568552. doi: 10.3389/fendo.2025.1568552. eCollection 2025.
Diabetic gastrointestinal diseases not only affect the quality of life of patients, but also bring heavy economic burden to patients. Understanding of the current features of diabetic gastrointestinal diseases-related clinical trials are important for improving designs of clinical trials and identifying neglected areas of study. Despite the high prevalence of gastrointestinal complications among diabetic patients, comprehensive analyses of registered clinical trials are lacking. This study aimed to present a scoping overview of diabetic gastrointestinal diseases-related clinical trials registered in ClinicalTrials.gov, ChiCTR and high-quality diabetic gastrointestinal diseases-related clinical trials published in Pubmed in the past 10 years.
The trials registered in ClinicalTrials.gov and ChiCTR databases from the establishment of the database to June 14,2024 were searched. Moreover, high-quality trials with impact factors of 5 points or more published in Pubmed from June 2014 to June 2024 were searched. The results were extracted and presented in tabular form.
Most studies focused on diabetic gastroparesis, with drug interventions being the most common. In addition, most studies were small sample sizes (≤100), randomized parallel controlled trials and 69.01% of the studies used different methods of blinding. Most studies did not conduct safety evaluation and follow-up.
The diagnostic criteria of diabetic gastrointestinal diseases were diverse. Furthermore, most studies on diabetic gastrointestinal diseases focused on diabetic gastroparesis. There was considerable heterogeneity in study designs and efficacy evaluations.
糖尿病胃肠疾病不仅影响患者生活质量，还给患者带来沉重经济负担。了解糖尿病胃肠疾病相关临床试验的当前特征，对于改进临床试验设计和识别被忽视的研究领域具有重要意义。尽管糖尿病患者胃肠道并发症的患病率很高，但缺乏对已注册临床试验的综合分析。本研究旨在对在ClinicalTrials.gov、中国临床试验注册中心（ChiCTR）注册的糖尿病胃肠疾病相关临床试验以及过去10年在Pubmed上发表的高质量糖尿病胃肠疾病相关临床试验进行范围综述。
检索ClinicalTrials.gov和ChiCTR数据库自建立至2024年6月14日注册的试验。此外，检索2014年6月至2024年6月在Pubmed上发表的影响因子为5分及以上的高质量试验。提取结果并以表格形式呈现。
大多数研究聚焦于糖尿病胃轻瘫，药物干预最为常见。此外，大多数研究样本量较小（≤100），为随机平行对照试验，69.01%的研究采用了不同的盲法。大多数研究未进行安全性评估和随访。
糖尿病胃肠疾病的诊断标准多样。此外，大多数关于糖尿病胃肠疾病的研究聚焦于糖尿病胃轻瘫。研究设计和疗效评估存在相当大的异质性。
