Clinical Characteristics of People With Long-term Type 1 Diabetes
1 other identifier
observational
400
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2022
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedFirst Posted
Study publicly available on registry
May 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
ExpectedMay 4, 2022
April 1, 2022
3.7 years
April 24, 2022
April 28, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
the changes of memory function
from May 2022 to December 2025
the changes of executive function
from May 2022 to December 2025
the changes of language function
from May 2022 to December 2025
the changes on magnetic resonance imaging(MRI)
from May 2022 to December 2025
the changes of bone mineral density(BMD)
from May 2022 to December 2025
- +2 more secondary outcomes
Study Arms (1)
long-term T1D
Subjects who has the T1D duration ≥10 years, with or without diabetic complications.
Interventions
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.
For each follow-up, fasting and stimulated C-peptide levels will be measured.
Genetic variations of interest will be detected with the blood sample collected at baseline.
For each follow-up, the dietary constitutes for the past 3 days will be recorded.
For each follow-up, the fecal and oral samples will be collected for measurement.
For each follow-up, the serum and urine samples will be collected for measurement.
For each follow-up, the peripheral blood mononuclear cells will be collected for measurement.
Eligibility Criteria
subjects are enrolled from hospital, primary care clinic, or community of the whole country
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
Changsha, Hunan, 410001, China
Biospecimen
whole blood, serum, peripheral blood mononuclear cells, urine, feces, saliva
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xia Li, MD/PHD
Central South University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Endocrinology, Institute of of Metabolism and Endocrinology, Nationa Clinical Research Center for Metabolic Diseases, Second Xiangya Hospital of Central South University
Study Record Dates
First Submitted
April 24, 2022
First Posted
May 4, 2022
Study Start
May 1, 2022
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2027
Last Updated
May 4, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share