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NCT Number: NCT05359796

Clinical Characteristics of People With Long-term Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University

Changsha, Hunan, 410001, China

Location status: Recruiting

Location contact

Xia Li, MD/PHD

CONTACT

[email protected]

+86 17373199692

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chronic hyperglycemia

Biological

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

Biological

For each follow-up, fasting and stimulated C-peptide levels will be measured.

Genetic variation

Genetic

Genetic variations of interest will be detected with the blood sample collected at baseline.

Dietary constitutes

Dietary Supplement

For each follow-up, the dietary constitutes for the past 3 days will be recorded.

Microbiome composition and function

Genetic

For each follow-up, the fecal and oral samples will be collected for measurement.

Metabolome composition

Biological

For each follow-up, the serum and urine samples will be collected for measurement.

Composition of peripheral blood immune cells

Biological

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

Primary outcomes

  1. the development or progression of diabetic nephropathy

    Time frame: from May 2022 to December 2025

    measured by urine microalbumin/creatinine

  2. the development or progression of diabetic retinopathy

    Time frame: from May 2022 to December 2025

    diagnosed by an ophthalmologist based on fundus photography

Secondary outcomes

  1. the changes of memory function

    Time frame: from May 2022 to December 2025

    measured by the Auditory Verbal Learning Test (AVLT)

  2. the changes of executive function

    Time frame: from May 2022 to December 2025

    measured by the Shape Trail Test (STT)

  3. the changes of language function

    Time frame: from May 2022 to December 2025

    measured by the Boston Naming Test (BNT)

  4. the changes on magnetic resonance imaging(MRI)

    Time frame: from May 2022 to December 2025

    the MRI reflects the changes of cerebral structure and functional connectivity

  5. the changes of bone mineral density(BMD)

    Time frame: from May 2022 to December 2025

    measured by dual x-ray absorbtiometry(DXA), indicating bone density

  6. the changes of brachial-ankle pulse wave velocity(baPWV)

    Time frame: from May 2022 to December 2025

    measured by ultrasound, indicating large artery stiffness

  7. the changes of carotid intima-media thickness(IMT)

    Time frame: from May 2022 to December 2025

    measured by ultrasound, indicating the form of carotid atherosclerotic plaque

Study contacts

Contact information is provided by the study sponsor or research team.

Xia Li, MD/PHD

CONTACT

[email protected]

+86 17373199692

Sponsors and collaborators

Lead sponsor

Second Xiangya Hospital of Central South University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
May 4, 2022
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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