Type 1 Diabetes Mellitus Maturity OnsetNCT05252728
Altered Faecal Microbiome and Metabolome in CT1D, AT1D and T2D
An observational study of Type 1 Diabetes Mellitus Maturity Onset, run by Second Xiangya Hospital of Central South University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 5 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus Maturity Onset
- How many people
- 372 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Diabetes diagnosed according to the report of WHO in 1999；
- Aged between 5 and 70 years old;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
Changsha, Hunan, 410011
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus Maturity Onset
- Keywords
- adult-onset type 1 diabetes, microbiota, metabolomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control | Not described | |
| Childhood-onset type 1 diabetes | Not described | |
| Adult-onset type 1 diabetes | Not described | |
| Type 2 diabetes | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences of β diversity of gut microbiota between diabetic groups and healthy control.
β diversity is based on metagenome analysis and statistical significance is estimated by permutational multivariate analysis of variance.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Feb 2019
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes Mellitus Maturity OnsetStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Xiao, Second Xiangya Hospital of Central South University
- Investigators
- Yang Xiao, MD/PhD, Principal investigator, Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252728
- Sponsor's protocol ID
- 2021AT1DDC
- Status last verified
- Apr 2023
- First submitted
- 13 Feb 2022
- Last updated
- 11 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34593612Leslie 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.
PubMed 34670785Fang 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.
PubMed 34620611Honkanen 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.
PubMed 32265922Hu J, Ding J, Li X, Li J, Zheng T, Xie L, Li C, Tang Y, Guo K, Huang J, Liu S, Yan J, Peng W, Hou C, Wen L, Xu A, Zhou Z, Xiao Y. Distinct signatures of gut microbiota and metabolites in different types of diabetes: a population-based cross-sectional study. EClinicalMedicine. 2023 Aug 3;62:102132. doi: 10.1016/j.eclinm.2023.102132. eCollection 2023 Aug.
PubMed 37593224
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altered Faecal Microbiome and Metabolome in Childhood-onset Type 1 Diabetes, Adult-onset Type 1 Diabetes and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05252728
- Acronym / sponsor ID
- 2021AT1DDC
- Conditions
- Type 1 Diabetes Mellitus Maturity Onset
- Keywords
- adult-onset type 1 diabetes, microbiota, metabolomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy control | – | – |
| Childhood-onset type 1 diabetes | – | – |
| Adult-onset type 1 diabetes | – | – |
| Type 2 diabetes | – | – |
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Diabetes diagnosed according to the report of WHO in 1999；
- Aged between 5 and 70 years old;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Background: PubMed 34593612Holt 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.
- Background: PubMed 34670785Leslie 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.
- Background: PubMed 34620611Fang 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.
- Background: PubMed 32265922Honkanen 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.
- Derived from this study: PubMed 37593224Hu J, Ding J, Li X, Li J, Zheng T, Xie L, Li C, Tang Y, Guo K, Huang J, Liu S, Yan J, Peng W, Hou C, Wen L, Xu A, Zhou Z, Xiao Y. Distinct signatures of gut microbiota and metabolites in different types of diabetes: a population-based cross-sectional study. EClinicalMedicine. 2023 Aug 3;62:102132. doi: 10.1016/j.eclinm.2023.102132. eCollection 2023 Aug.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Xiao, MD/PhD principal investigator
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus Maturity Onset, run by Second Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences of β diversity of gut microbiota between diabetic groups and healthy control. (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05252728, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.