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临床试验/NCT05752851
NCT05752851招募中不适用

Nanjing First Hospital,Nanjing Medical University

Nanjing First Hospital, Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Fecal 16S rRNA gene sequencing

研究概览

简要总结

This Study aims to compare the characteristics of gut microbiota between the newly diagnosed T2DM and healthy subjects, and analysis the related clinical indicators that may affect the composition of gut microbiota.

详细描述

Previous studies have shown that gut microbiota imbalance is closely related to a variety of diseases, such as inflammatory bowel diseases (IBD), colorectal cancer (CRC), Alzheimer's disease (AD) and cardiovascular diseases. In recent years, more and more studies have found that gut microbiota plays an important role in chronic metabolic diseases such as obesity, fatty liver and diabetes. gut microbiota disorder may lead to insulin resistance,pancreatic islets injury and disorder of glycolipid metabolism through multiple metabolic pathways such as endotoxin, short chain fatty acids, bile acids, amino acids, promote the occurrence and development of T2DM. At present, there are relatively few population-based studies to assess the relationship between gut microbiota and diabetes, and the results are inconsistent or even contradictory, which may be due to the influence of the research population, disease status, diet, drugs and even detection technology. Therefore, the purpose of this study is to explore the difference of intestinal microbial characteristics between the initially diagnosed T2DM and the control group by using 16S rRNA gene sequencing analysis technology, so as to increase the understanding of the possible relationship between T2DM and intestinal microbiota, and provide theoretical support and direction guidance for the future biological treatment of diabetes.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1)18-65 years old 2)have no history of diabetes 3)fasting blood glucose <5.6 mmol/L 4) HbA1c<6.0%.

排除标准

  • 1)BMI≥28kg/m2 2) People with type 1 diabetes, special type diabetes and pregnancy diabetes 3) Use antispasmodics, expanders, probiotics, prebiotics, antibacterial drugs or other drugs that affect intestinal microorganisms in the past month 4) Having inflammation, tumor, ulcer and other intestinal organic diseases, tumor, etc 5) History of abdominal surgery or gastrointestinal surgery 6) Suffer from mental illness or alcoholism, drug abuse or drug abuse. 7) Combined with other serious systemic diseases, such as cardiovascular disease, digestive disease, endocrine disease, skin disease, autoimmune disease, tumor, etc.

结局指标

主要结局

Fecal 16S rRNA gene sequencing

时间窗: Day one

Fecal 16S rRNA gene sequencing results of two group

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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