Clinical trial NCT05359796: Clinical Characteristics of People With Long-term Type 1 Diabetes
Official title: Clinical Characteristics of People With Long-term Type 1 Diabetes: a Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects are enrolled from hospital, primary care clinic, or community of the whole country

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.

Eligibility 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

Primary outcomes:
measure: the development or progression of diabetic nephropathy
timeFrame: from May 2022 to December 2025
measure: the development or progression of diabetic retinopathy
timeFrame: from May 2022 to December 2025
Secondary outcomes:
measure: the changes of memory function
timeFrame: from May 2022 to December 2025
measure: the changes of executive function
timeFrame: from May 2022 to December 2025
measure: the changes of language function
timeFrame: from May 2022 to December 2025
measure: the changes on magnetic resonance imaging(MRI)
timeFrame: from May 2022 to December 2025
measure: the changes of bone mineral density(BMD)
timeFrame: from May 2022 to December 2025
measure: the changes of brachial-ankle pulse wave velocity(baPWV)
timeFrame: from May 2022 to December 2025
measure: the changes of carotid intima-media thickness(IMT)
timeFrame: from May 2022 to December 2025
Other outcomes:
Locations:
city: Changsha
country: China
facility: Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
state: Hu Nan
Study officials:
affiliation: Central South University
name: Xia Li, MD/PHD
role: PRINCIPAL_INVESTIGATOR
References: