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NCT05359796 | RECRUITING | Type 1 Diabetes


Clinical Characteristics of People With Long-term Type 1 Diabetes
Sponsor:

Second Xiangya Hospital of Central South University

Information provided by (Responsible Party):

ξ Ali

Brief 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 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.

Condition or disease

Type 1 Diabetes

Intervention/treatment

Chronic hyperglycemia

Residual islet function

Genetic variation

Dietary constitutes

Microbiome composition and function

Metabolome composition

Composition of peripheral blood immune cells

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 Type : OBSERVATIONAL
Estimated Enrollment : 400 participants
Official Title : Clinical Characteristics of People With Long-term Type 1 Diabetes: a Cohort Study
Actual Study Start Date : 2022-05-01
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2027-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

Clinical Characteristics of People With Long-term Type 1 Diabetes

Location Details

NCT05359796


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Locations


RECRUITING

China, Hunan

Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University

Changsha, Hunan, China, 410001

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