Clinical Characteristics of People With Long-term Type 1 Diabetes

Recruiting

• Conditions: Type 1 Diabetes
• Interventions: 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

• Registration Number: NCT05359796
• Lead Sponsor: Second Xiangya Hospital of Central South University

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.

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 Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-24
• Study First Submitted QC: 2022-04-28
• Last Update Submitted: 2022-04-28
• Study Start: 2022-05-01
• Study First Posted: 2022-05-04
• Last Update Posted: 2022-05-04
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
the development or progression of diabetic retinopathy	from May 2022 to December 2025	diagnosed by an ophthalmologist based on fundus photography
the development or progression of diabetic nephropathy	from May 2022 to December 2025	measured by urine microalbumin/creatinine

Secondary Outcome Measures

Name	Time	Method
the changes of executive function	from May 2022 to December 2025	measured by the Shape Trail Test (STT)
the changes on magnetic resonance imaging(MRI)	from May 2022 to December 2025	the MRI reflects the changes of cerebral structure and functional connectivity
the changes of carotid intima-media thickness(IMT)	from May 2022 to December 2025	measured by ultrasound, indicating the form of carotid atherosclerotic plaque
the changes of memory function	from May 2022 to December 2025	measured by the Auditory Verbal Learning Test (AVLT)
the changes of bone mineral density(BMD)	from May 2022 to December 2025	measured by dual x-ray absorbtiometry(DXA), indicating bone density
the changes of brachial-ankle pulse wave velocity(baPWV)	from May 2022 to December 2025	measured by ultrasound, indicating large artery stiffness
the changes of language function	from May 2022 to December 2025	measured by the Boston Naming Test (BNT)

Trial Locations

Locations (1)

Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hu Nan, China