Clinical Characteristics of People With Long-term Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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

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Type 1 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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long-term T1D

Subjects who has the T1D duration ≥10 years, with or without diabetic complications.

Chronic hyperglycemia

Intervention Type BIOLOGICAL

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 function

Intervention Type BIOLOGICAL

For each follow-up, fasting and stimulated C-peptide levels will be measured.

Genetic variation

Intervention Type GENETIC

Genetic variations of interest will be detected with the blood sample collected at baseline.

Dietary constitutes

Intervention Type DIETARY_SUPPLEMENT

For each follow-up, the dietary constitutes for the past 3 days will be recorded.

Microbiome composition and function

Intervention Type GENETIC

For each follow-up, the fecal and oral samples will be collected for measurement.

Metabolome composition

Intervention Type BIOLOGICAL

For each follow-up, the serum and urine samples will be collected for measurement.

Composition of peripheral blood immune cells

Intervention Type BIOLOGICAL

For each follow-up, the peripheral blood mononuclear cells will be collected for measurement.

Interventions

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Chronic hyperglycemia

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.

Intervention Type BIOLOGICAL

Residual islet function

For each follow-up, fasting and stimulated C-peptide levels will be measured.

Intervention Type BIOLOGICAL

Genetic variation

Genetic variations of interest will be detected with the blood sample collected at baseline.

Intervention Type GENETIC

Dietary constitutes

For each follow-up, the dietary constitutes for the past 3 days will be recorded.

Intervention Type DIETARY_SUPPLEMENT

Microbiome composition and function

For each follow-up, the fecal and oral samples will be collected for measurement.

Intervention Type GENETIC

Metabolome composition

For each follow-up, the serum and urine samples will be collected for measurement.

Intervention Type BIOLOGICAL

Composition of peripheral blood immune cells

For each follow-up, the peripheral blood mononuclear cells will be collected for measurement.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Xia Li

Professor, Department of Endocrinology, Institute of of Metabolism and Endocrinology, Nationa Clinical Research Center for Metabolic Diseases, Second Xiangya Hospital of Central South University

Responsibility Role PRINCIPAL_INVESTIGATOR