Type 1 DiabetesNCT05359796
Clinical Characteristics of People With Long-term Type 1 Diabetes
An observational study of Type 1 Diabetes, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Type 1 diabetes (T1D) is characterized by absolute insulin deficiency. Although the discovery and application of exogenous insulin has prolonged the lifespan of T1D patients, the chronic diabetic complications caused by long-term poor glycemic control will still reduce patients' quality of life and the overall life… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Chronic hyperglycemia, Residual islet function and Genetic variation
- Type of treatment
- Pill or oral medicine
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: subjects are enrolled from hospital, primary care clinic, or community of the whole country
Who may be able to join
- Individuals diagnosed with type 1 diabetes(T1D) according to the 1999 World Health Organization report
- Insulin dependence from disease onset
- with T1D duration of ≥10 years
- able to understand the procedures and methods of this study, voluntarily participate in the study, and agree to sign the informed consent form
Who cannot join
- patients with type 2 diabetes, gestational diabetes, or specific types of diabetes
- patients with mental disability or have any other condition or disease that may hamper compliance with the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
Changsha, Hunan, 410001
Xia Li, MD/PHD, +86 17373199692, lixia2014@vip.163.com
About this study
Official title: Clinical Characteristics of People With Long-term Type 1 Diabetes: a Cohort Study
Type 1 diabetes (T1D) is characterized by absolute insulin deficiency. Although the discovery and application of exogenous insulin has prolonged the lifespan of T1D patients, the chronic diabetic complications caused by long-term poor glycemic control will still reduce patients' quality of life and the overall life expectancy. According to the studies focused on long-term T1D, part of the patients with long disease duration showed resistance to microvascular complications, and several protective factors have been identified. The prevalence of T1D in China is extremely low compared to that in the western world, and little is known about the characteristics of patients with long-term T1D in China. Therefore, this study is designed to collect variable clinical and laboratory features of patients with long-term T1D, explore the risk and protective factors for the development of microvascular complications, and provide reference for the prediction and prevention of these complications.
Read the detailed description
This is a single-center, prospective, observational study. The investigators propose to enroll 400 patients with type 1 diabetes (T1D) ≥10 years. The patients will be followed up annually for 3 years.
In order to ensure high quality data, two staff are responsible for the input of original data into the database to check and confirm the accuracy. When the data entered by two people is inconsistent, the auxiliary staff decides which data to use.
Missing data will be filled in with the multiple imputation method. The regression analysis will be used to explore the risk and protective factors for the development and progression of microvascular complications.
- Conditions
- Type 1 Diabetes
- Being tested
- Chronic hyperglycemia, Residual islet function, Genetic variation, Dietary constitutes, Microbiome composition and function
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic hyperglycemiaBiological
For each follow-up, the glycated albumin(GA) reflecting glycemic control of the past 2-3 weeks, the glycated hemoglobin(HbA1c) reflecting glycemic control of the past 2-3 months, and the advanced glycation end products(AGEs) will be measured.
Residual islet functionBiological
For each follow-up, fasting and stimulated C-peptide levels will be measured.
Genetic variationGenetic
Genetic variations of interest will be detected with the blood sample collected at baseline.
Dietary constitutesDietary supplement
For each follow-up, the dietary constitutes for the past 3 days will be recorded.
Microbiome composition and functionGenetic
For each follow-up, the fecal and oral samples will be collected for measurement.
Metabolome compositionBiological
For each follow-up, the serum and urine samples will be collected for measurement.
Composition of peripheral blood immune cellsBiological
For each follow-up, the peripheral blood mononuclear cells will be collected for measurement.
| Study group | Role | What they receive |
|---|---|---|
| long-term T1D | Subjects who has the T1D duration ≥10 years, with or without diabetic complications. Receives: Biological: Chronic hyperglycemia; Biological: Residual islet function; Genetic: Genetic variation; Dietary Supplement: Dietary constitutes; Genetic: Microbiome composition and function; Biological: Metabolome composition; Biological: Composition of peripheral blood immune cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
the development or progression of diabetic nephropathy
measured by urine microalbumin/creatinine
Measured: from May 2022 to December 2025
the development or progression of diabetic retinopathy
diagnosed by an ophthalmologist based on fundus photography
Measured: from May 2022 to December 2025
Secondary outcomes (7)
the changes of memory function
measured by the Auditory Verbal Learning Test (AVLT)
Measured: from May 2022 to December 2025
the changes of executive function
measured by the Shape Trail Test (STT)
Measured: from May 2022 to December 2025
the changes of language function
measured by the Boston Naming Test (BNT)
Measured: from May 2022 to December 2025
the changes on magnetic resonance imaging(MRI)
the MRI reflects the changes of cerebral structure and functional connectivity
Measured: from May 2022 to December 2025
the changes of bone mineral density(BMD)
measured by dual x-ray absorbtiometry(DXA), indicating bone density
Measured: from May 2022 to December 2025
the changes of brachial-ankle pulse wave velocity(baPWV)
measured by ultrasound, indicating large artery stiffness
Measured: from May 2022 to December 2025
the changes of carotid intima-media thickness(IMT)
measured by ultrasound, indicating the form of carotid atherosclerotic plaque
Measured: from May 2022 to December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 May 2022 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xia Li, Second Xiangya Hospital of Central South University
- Investigators
- Xia Li, MD/PHD, Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359796
- Sponsor's protocol ID
- long-term T1D 2022
- Status last verified
- Apr 2022
- First submitted
- 24 Apr 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tang R, Shi M, Ji X, Zhang Y, Fan L, Huang F, Li X. Integrative oral and gut microbiome profiling highlights microbial correlates of complications in type 1 diabetes: a cross-sectional analysis. Cardiovasc Diabetol. 2025 Dec 24;24(1):461. doi: 10.1186/s12933-025-03012-z.
PubMed 41444596
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of People With Long-term Type 1 Diabetes: a Cohort Study
- ClinicalTrials.gov ID
- NCT05359796
- Acronym / sponsor ID
- long-term T1D 2022
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 May 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.
Type 1 diabetes (T1D) is characterized by absolute insulin deficiency. Although the discovery and application of exogenous insulin has prolonged the lifespan of T1D patients, the chronic diabetic complications caused by long-term poor glycemic control will still reduce patients' quality of life and the overall life expectancy. According to the studies focused on long-term T1D, part of the patients with long disease duration showed resistance to microvascular complications, and several protective factors have been identified. The prevalence of T1D in China is extremely low compared to that in the western world, and little is known about the characteristics of patients with long-term T1D in China. Therefore, this study is designed to collect variable clinical and laboratory features of patients with long-term T1D, explore the risk and protective factors for the development of microvascular complications, and provide reference for the prediction and prevention of these complications.
Detailed description
This is a single-center, prospective, observational study. The investigators propose to enroll 400 patients with type 1 diabetes (T1D) ≥10 years. The patients will be followed up annually for 3 years.
In order to ensure high quality data, two staff are responsible for the input of original data into the database to check and confirm the accuracy. When the data entered by two people is inconsistent, the auxiliary staff decides which data to use.
Missing data will be filled in with the multiple imputation method. The regression analysis will be used to explore the risk and protective factors for the development and progression of microvascular complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| long-term T1D | – | Biological: Chronic hyperglycemia, Biological: Residual islet function, Genetic: Genetic variation, Dietary Supplement: Dietary constitutes, Genetic: Microbiome composition and function, Biological: Metabolome composition, Biological: Composition of peripheral blood immune cellsSubjects who has the T1D duration ≥10 years, with or without diabetic complications. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- subjects are enrolled from hospital, primary care clinic, or community of the whole country
Key inclusion criteria (4 listed)
- Individuals diagnosed with type 1 diabetes(T1D) according to the 1999 World Health Organization report
- Insulin dependence from disease onset
- with T1D duration of ≥10 years
- able to understand the procedures and methods of this study, voluntarily participate in the study, and agree to sign the informed consent form
Key exclusion criteria (2 listed)
- patients with type 2 diabetes, gestational diabetes, or specific types of diabetes
- patients with mental disability or have any other condition or disease that may hamper compliance with the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronic hyperglycemiaFor each follow-up, the glycated albumin(GA) reflecting glycemic control of the past 2-3 weeks, the glycated hemoglobin(HbA1c) reflecting glycemic control of the past 2-3 months, and the advanced glycation end products(AGEs) will be measured. | Biological | long-term T1D |
| Residual islet functionFor each follow-up, fasting and stimulated C-peptide levels will be measured. | Biological | long-term T1D |
| Genetic variationGenetic variations of interest will be detected with the blood sample collected at baseline. | Genetic | long-term T1D |
| Dietary constitutesFor each follow-up, the dietary constitutes for the past 3 days will be recorded. | Dietary supplement | long-term T1D |
| Microbiome composition and functionFor each follow-up, the fecal and oral samples will be collected for measurement. | Genetic | long-term T1D |
| Metabolome compositionFor each follow-up, the serum and urine samples will be collected for measurement. | Biological | long-term T1D |
| Composition of peripheral blood immune cellsFor each follow-up, the peripheral blood mononuclear cells will be collected for measurement. | Biological | long-term T1D |
Primary outcome
the development or progression of diabetic nephropathy
Time frame: from May 2022 to December 2025
measured by urine microalbumin/creatinine
the development or progression of diabetic retinopathy
Time frame: from May 2022 to December 2025
diagnosed by an ophthalmologist based on fundus photography
7 secondary outcomes
the changes of memory function
Time frame: from May 2022 to December 2025
the changes of executive function
Time frame: from May 2022 to December 2025
the changes of language function
Time frame: from May 2022 to December 2025
the changes on magnetic resonance imaging(MRI)
Time frame: from May 2022 to December 2025
the changes of bone mineral density(BMD)
Time frame: from May 2022 to December 2025
the changes of brachial-ankle pulse wave velocity(baPWV)
Time frame: from May 2022 to December 2025
the changes of carotid intima-media thickness(IMT)
Time frame: from May 2022 to December 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Derived from this study: PubMed 41444596Tang R, Shi M, Ji X, Zhang Y, Fan L, Huang F, Li X. Integrative oral and gut microbiome profiling highlights microbial correlates of complications in type 1 diabetes: a cross-sectional analysis. Cardiovasc Diabetol. 2025 Dec 24;24(1):461. doi: 10.1186/s12933-025-03012-z.
- Individual participant dataSharing planned: No
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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.
Xia Li, MD/PHD principal investigator
Central South University
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, 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 4 May 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xia Li, MD/PHD (+86 17373199692, lixia2014@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the development or progression of diabetic nephropathy (time frame: from May 2022 to December 2025). The study lists 2 primary outcomes in all. 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 NCT05359796, which also lists 1 linked publication.
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 4 May 2022.