Clinical Characteristics of People With Long-term Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05359796
• Other study ID #: long-term T1D 2022
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2022
• Source: Second Xiangya Hospital of Central South University
• Contact: Xia Li, MD/PHD
• Phone: +86 17373199692
• Email: lixia2014[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.
• 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.
• Composition of peripheral blood immune cells
For each follow-up, the peripheral blood mononuclear cells will be collected for measurement.

Locations

Country	Name	City	State
China	Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University	Changsha	Hu Nan

Sponsors (1)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the development or progression of diabetic nephropathy	measured by urine microalbumin/creatinine	from May 2022 to December 2025
Primary	the development or progression of diabetic retinopathy	diagnosed by an ophthalmologist based on fundus photography	from May 2022 to December 2025
Secondary	the changes of memory function	measured by the Auditory Verbal Learning Test (AVLT)	from May 2022 to December 2025
Secondary	the changes of executive function	measured by the Shape Trail Test (STT)	from May 2022 to December 2025
Secondary	the changes of language function	measured by the Boston Naming Test (BNT)	from May 2022 to December 2025
Secondary	the changes on magnetic resonance imaging(MRI)	the MRI reflects the changes of cerebral structure and functional connectivity	from May 2022 to December 2025
Secondary	the changes of bone mineral density(BMD)	measured by dual x-ray absorbtiometry(DXA), indicating bone density	from May 2022 to December 2025
Secondary	the changes of brachial-ankle pulse wave velocity(baPWV)	measured by ultrasound, indicating large artery stiffness	from May 2022 to December 2025
Secondary	the changes of carotid intima-media thickness(IMT)	measured by ultrasound, indicating the form of carotid atherosclerotic plaque	from May 2022 to December 2025