Clinical Characteristics of People With Long-term Type 1 Diabetes

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Biological: Chronic hyperglycemia; Biological: Residual islet function; Genetic: Genetic variation; Dietary supplement: Dietary constitutes; Genetic: Microbiome composition and function; Biological: Metabolome composition; Biological: Composition of peripheral blood immune cells

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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Xia Li, MD/PHD; Phone Number: +86 17373199692; Email: lixia2014@vip.163.com

Study Locations

• China
  • Hu Nan
    • Changsha, Hu Nan, China, 410001
      • Recruiting
      • Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
      • Contact: Xia Li, MD/PHD; Phone Number: +86 17373199692; Email: lixia2014@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

subjects are enrolled from hospital, primary care clinic, or community of the whole country

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

long-term T1D; Subjects who has the T1D duration ≥10 years, with or without diabetic complications.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the development or progression of diabetic nephropathy	measured by urine microalbumin/creatinine	from May 2022 to December 2025
the development or progression of diabetic retinopathy	diagnosed by an ophthalmologist based on fundus photography	from May 2022 to December 2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the changes of memory function	measured by the Auditory Verbal Learning Test (AVLT)	from May 2022 to December 2025
the changes of executive function	measured by the Shape Trail Test (STT)	from May 2022 to December 2025
the changes of language function	measured by the Boston Naming Test (BNT)	from May 2022 to December 2025
the changes on magnetic resonance imaging(MRI)	the MRI reflects the changes of cerebral structure and functional connectivity	from May 2022 to December 2025
the changes of bone mineral density(BMD)	measured by dual x-ray absorbtiometry(DXA), indicating bone density	from May 2022 to December 2025
the changes of brachial-ankle pulse wave velocity(baPWV)	measured by ultrasound, indicating large artery stiffness	from May 2022 to December 2025
the changes of carotid intima-media thickness(IMT)	measured by ultrasound, indicating the form of carotid atherosclerotic plaque	from May 2022 to December 2025

Collaborators and Investigators

• Sponsor: Second Xiangya Hospital of Central South University
• Investigators: Principal Investigator: Xia Li, MD/PHD, Central South University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: April 24, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: long-term T1D 2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No