Altered Faecal Microbiome and Metabolome in CT1D, AT1D and T2D

July 7, 2023 updated by: Yang Xiao, Second Xiangya Hospital of Central South University

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

372

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410011
        • Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with childhood-onset type 1 diabetes, adult-onset type 1 diabetes or type 2 diabetes. Healthy conrols recruited at the Second Xiangya Hospital of Central South University in Changsha.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy control
Type 2 diabetes
Childhood-onset type 1 diabetes
Adult-onset type 1 diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

February 13, 2022

First Submitted That Met QC Criteria

February 13, 2022

First Posted (Actual)

February 23, 2022

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021AT1DDC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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