Altered Faecal Microbiome and Metabolome in CT1D, AT1D and T2D

Type 1 Diabetes Mellitus Maturity Onset Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05252728
• Other study ID #: 2021AT1DDC
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: April 30, 2022

Study information

• Verified date: April 2023
• Source: Second Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Type 1 Diabetes Mellitus Maturity Onset

Locations

Country	Name	City	State
China	Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (4)

Fang Y, Zhang C, Shi H, Wei W, Shang J, Zheng R, Yu L, Wang P, Yang J, Deng X, Zhang Y, Tang S, Shi X, Liu Y, Yang H, Yuan Q, Zhai R, Yuan H. Characteristics of the Gut Microbiota and Metabolism in Patients With Latent Autoimmune Diabetes in Adults: A Case-Control Study. Diabetes Care. 2021 Dec;44(12):2738-2746. doi: 10.2337/dc20-2975. Epub 2021 Oct 7. Erratum In: Diabetes Care. 2022 Mar 1;45(3):761. — View Citation

Holt RIG, DeVries JH, Hess-Fischl A, Hirsch IB, Kirkman MS, Klupa T, Ludwig B, Norgaard K, Pettus J, Renard E, Skyler JS, Snoek FJ, Weinstock RS, Peters AL. The Management of Type 1 Diabetes in Adults. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2021 Nov;44(11):2589-2625. doi: 10.2337/dci21-0043. Epub 2021 Sep 30. — View Citation

Honkanen J, Vuorela A, Muthas D, Orivuori L, Luopajarvi K, Tejesvi MVG, Lavrinienko A, Pirttila AM, Fogarty CL, Harkonen T, Ilonen J, Ruohtula T, Knip M, Koskimaki JJ, Vaarala O. Fungal Dysbiosis and Intestinal Inflammation in Children With Beta-Cell Autoimmunity. Front Immunol. 2020 Mar 19;11:468. doi: 10.3389/fimmu.2020.00468. eCollection 2020. — View Citation

Leslie RD, Evans-Molina C, Freund-Brown J, Buzzetti R, Dabelea D, Gillespie KM, Goland R, Jones AG, Kacher M, Phillips LS, Rolandsson O, Wardian JL, Dunne JL. Adult-Onset Type 1 Diabetes: Current Understanding and Challenges. Diabetes Care. 2021 Nov;44(11):2449-2456. doi: 10.2337/dc21-0770. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences of ß diversity of gut microbiota between diabetic groups and healthy control.	ß diversity is based on metagenome analysis and statistical significance is estimated by permutational multivariate analysis of variance.	at baseline