NCT05359796

Clinical Characteristics of People With Long-term Type 1 Diabetes

Clinical Characteristics of People With Long-term Type 1 Diabetes: a Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Second Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
BIOLOGICAL	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.
BIOLOGICAL	Residual islet function	For each follow-up, fasting and stimulated C-peptide levels will be measured.
GENETIC	Genetic variation	Genetic variations of interest will be detected with the blood sample collected at baseline.
DIETARY_SUPPLEMENT	Dietary constitutes	For each follow-up, the dietary constitutes for the past 3 days will be recorded.
GENETIC	Microbiome composition and function	For each follow-up, the fecal and oral samples will be collected for measurement.
BIOLOGICAL	Metabolome composition	For each follow-up, the serum and urine samples will be collected for measurement.
BIOLOGICAL	Composition of peripheral blood immune cells	For each follow-up, the peripheral blood mononuclear cells will be collected for measurement.

Timeline

• Start date: 2022-05-01
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2022-05-04
• Last updated: 2022-05-04

Locations

1 site across 1 country: China