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Altered Faecal Microbiome and Metabolome in CT1D, AT1D and T2D

Sponsor
Second Xiangya Hospital of Central South University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05252728
Collaborator
(none)
200
Enrollment
1
Location
86.9
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Altered Faecal Microbiome and Metabolome in Childhood-onset Type 1 Diabetes, Adult-onset Type 1 Diabetes and Type 2 Diabetes
    Actual Study Start Date :
    Jan 1, 2016
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Mar 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Healthy control
    Childhood-onset type 1 diabetes
    Adult-onset type 1 diabetes
    Type 2 diabetes

    Outcome Measures

    Primary Outcome Measures

    1. Differences of β diversity of gut microbiota between diabetic groups and healthy control. [at baseline]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Diabetes diagnosed according to the report of WHO in 1999；

    2. Aged between 5 and 70 years old;

    Exclusion Criteria:

    1. Severe chronic cardiovascular or cerebrovascular disease；

    2. Severe abnormalities in liver or renal function;

    3. Hyperthyroidism; or other autoimmune diseases;

    4. Tumors, surgery or pregnancy;

    5. Treatments with oral hypoglycemic agents or immunomodulators;

    6. Subjects who had taken probiotics, prebiotics within one week or antibiotics within one month.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University Changsha Hunan China 410011

    Sponsors and Collaborators

    • Second Xiangya Hospital of Central South University

    Investigators

    • Principal Investigator: Yang Xiao, MD/PhD, Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University, China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    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
    ClinicalTrials.gov Identifier:
    NCT05252728
    Other Study ID Numbers:
    • 2021AT1DDC
    First Posted:
    Feb 23, 2022
    Last Update Posted:
    Feb 23, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by 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
    adult-onset type 1 diabetes
    microbiota
    metabolomics
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 1
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Feb 23, 2022