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Clinical Trials/NCT05252728
NCT05252728
Completed
Not Applicable

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 site in 1 country372 target enrollmentFebruary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes Mellitus Maturity Onset
Sponsor
Second Xiangya Hospital of Central South University
Enrollment
372
Locations
1
Primary Endpoint
Differences of β diversity of gut microbiota between diabetic groups and healthy control.
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
April 30, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Second Xiangya Hospital of Central South University
Responsible Party
Principal Investigator
Principal Investigator

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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

Time Frame: at baseline

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

Study Sites (1)

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