Clinical Characteristics of People With Long-term Type 1 Diabetes

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• the development or progression of diabetic nephropathy [Срок оценки: from May 2022 to December 2025]
• the development or progression of diabetic retinopathy [Срок оценки: from May 2022 to December 2025]

Вторичные конечные точки (7)

• the changes of memory function [Срок оценки: from May 2022 to December 2025]
• the changes of executive function [Срок оценки: from May 2022 to December 2025]
• the changes of language function [Срок оценки: from May 2022 to December 2025]
• the changes on magnetic resonance imaging(MRI) [Срок оценки: from May 2022 to December 2025]
• the changes of bone mineral density(BMD) [Срок оценки: from May 2022 to December 2025]
• the changes of brachial-ankle pulse wave velocity(baPWV) [Срок оценки: from May 2022 to December 2025]
• the changes of carotid intima-media thickness(IMT) [Срок оценки: from May 2022 to December 2025]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South Universi — Чанша

Идентификаторы

NCT: NCT05359796 · long-term T1D 2022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗