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Clinical Characteristics of People With Long-term Type 1 Diabetes

C

Central South University

Status

Enrolling

Conditions

Type 1 Diabetes

Treatments

Biological: Residual islet function
Biological: Composition of peripheral blood immune cells
Dietary Supplement: Dietary constitutes
Biological: Chronic hyperglycemia
Genetic: Genetic variation
Genetic: Microbiome composition and function
Biological: Metabolome composition

Study type

Observational

Funder types

Other

Identifiers

NCT05359796
long-term T1D 2022

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

400 participants in 1 patient group

long-term T1D
Description:
Subjects who has the T1D duration ≥10 years, with or without diabetic complications.
Treatment:
Biological: Residual islet function
Dietary Supplement: Dietary constitutes
Biological: Composition of peripheral blood immune cells
Biological: Metabolome composition
Genetic: Microbiome composition and function
Biological: Chronic hyperglycemia
Genetic: Genetic variation

Trial contacts and locations

1

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Central trial contact

Xia Li, MD/PHD

Data sourced from clinicaltrials.gov

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