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临床试验/NCT05252728
NCT05252728已完成不适用

Altered Faecal Microbiome and Metabolome in Childhood-onset Type 1 Diabetes, Adult-onset Type 1 Diabetes and Type 2 Diabetes

Second Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 372 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
372
试验地点
1
主要终点
Differences of β diversity of gut microbiota between diabetic groups and healthy control.

研究概览

简要总结

To elucidate the characteristics of global gut microbiota and fecal/serum metabolites in patients with childhood-onset type 1 diabetes, adult-onset type 1 diabetes or type 2 diabetes.

详细描述

Type 1 diabetes is caused by autoimmune destruction of pancreatic beta cells, leading to severe insulin deficiency and requiring insulin therapy. It is typically considered a disease of childhood and adolescence, but recent epidemiological data have shown that over half of all new-onset type 1 diabetes cases occur in adults worldwide. There are genetic, immune and metabolic differences between adult- and childhood-onset type 1 diabetes, revealing the underlying molecular basis of type 1 diabetes onset at diverse ages may differ. Accurate diagnosis is of great importance because the best treatment for different types of diabetes is divergent. Misdiagnosing type 2 diabetes as type 1 diabetes can lead to unnecessary initial insulin therapy, resulting in higher costs and more side effects. Thus, it is critical to identify the molecular basis and new diagnostic biomarkers for adult-onset type 1 diabetes.

Nonetheless, environmental exposures, in particular the immense intestinal microbiota and its derivatives, have been widely investigated. Indeed, patients with childhood-onset type 1 diabetes or type 2 diabetes exhibit compositional alterations in gut microbiota. However, gut microbiota in adult-onset type 1 diabetes has not been elucidated, and little is known about the shared and distinct microbial characteristics in adult-onset type 1 diabetes versus childhood-onset type 1 diabetes or type 2 diabetes.

Thus, this study is a cross-sectional study. 4 groups of subjects were recruited for metagenome and metabolome analysis, including healthy controls and patients with childhood-onset type 1 diabetes, adult-onset type 1 diabetes or type 2 diabetes. All subjects recruited meet the inclusion or exclusion criteria and written informed consent was obtained from each participant at enrollment.

研究设计

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

入排标准

年龄范围
5 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diabetes diagnosed according to the report of WHO in 1999;
  • Aged between 5 and 70 years old;

排除标准

  • Severe chronic cardiovascular or cerebrovascular disease;
  • Severe abnormalities in liver or renal function;
  • Hyperthyroidism; or other autoimmune diseases;
  • Tumors, surgery or pregnancy;
  • Treatments with oral hypoglycemic agents or immunomodulators;
  • Subjects who had taken probiotics, prebiotics within one week or antibiotics within one month.

结局指标

主要结局

Differences of β diversity of gut microbiota between diabetic groups and healthy control.

时间窗: at baseline

β diversity is based on metagenome analysis and statistical significance is estimated by permutational multivariate analysis of variance.

次要结局

未报告次要终点

研究者

发起方
Second Xiangya Hospital of Central South University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yang Xiao

Associate Professor, Department of Metabolism and Endocrinology, Institute of Metabolism and Endocrinology, National Clinical Research Center for Metabolic Diseases, Second Xiangya Hospital, Central South University

Second Xiangya Hospital of Central South University

研究点 (1)

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