Menu
Recruiting NCT05359796

Clinical Characteristics of People With Long-term Type 1 Diabetes

— Observational Type 1 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chronic hyperglycemia, Residual islet function, Genetic variation, Dietary constitutes.
Who it may be relevant to
Registry conditions: Type 1 Diabetes. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • the development or progression of diabetic nephropathy [Time frame: from May 2022 to December 2025]
  • the development or progression of diabetic retinopathy [Time frame: from May 2022 to December 2025]
Secondary outcome measures (7)
  • the changes of memory function [Time frame: from May 2022 to December 2025]
  • the changes of executive function [Time frame: from May 2022 to December 2025]
  • the changes of language function [Time frame: from May 2022 to December 2025]
  • the changes on magnetic resonance imaging(MRI) [Time frame: from May 2022 to December 2025]
  • the changes of bone mineral density(BMD) [Time frame: from May 2022 to December 2025]
  • the changes of brachial-ankle pulse wave velocity(baPWV) [Time frame: from May 2022 to December 2025]
  • the changes of carotid intima-media thickness(IMT) [Time frame: from May 2022 to December 2025]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South Universi — Changsha

Identifiers

NCT: NCT05359796 · long-term T1D 2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗