Cohort Study of Patients With Type 1 Diabetes：Clarifing the Underlying Hereditary and Autoimmune Pathogenic Factors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2,110
- Locations
- 1
- Primary Endpoint
- Effects of structured education on β-cell endocrine function progression of T1D patients.
Study Overview
Brief Summary
This study aims to clarify the underlying hereditary and autoimmune factors that contribute to clinical type 1 diabetes and gain a better understanding of the natural history of the disease.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diabetes diagnosed according to the report of WHO (World Health Organization) in 1999;
- •insulin dependence from disease onset,thus diagnosed with type 1 diabetes;
- •all patients gave informed consent to participate in the study and the protocol was approved by the Research Ethics Committee in second Xiangya hospital, Central South University.
Exclusion Criteria
- •secondary diabetes mellitus;
- •pregnant women;
- •malignant disease.
Outcomes
Primary Outcomes
Effects of structured education on β-cell endocrine function progression of T1D patients.
Time Frame: Baseline and every three months afterwards.
The natural progression of patients' β-cell endocrine functions was assessed by fasting C-peptide (FCP) and postprandial C-peptide (PCP) at each visit. FCP and PCP levels were measured at initial recruitment and every three months after that. The decay rate of β-cell endocrine function of patients in the two groups were compared. Serum C-peptide levels were measured by a chemiluminescence method using a commercial available kit (Adiva Centaur System, Siemens, Germany).
Secondary Outcomes
- Effects of structured education on blood sugar control.(Baseline and every three months afterwards.)
- Effects of structured education on metabolic control.(Baseline and every three months afterwards.)
Investigators
Zhiguang Zhou
Professor,Institute of Metabolism and Endocrinology, The Second Xiangya Hospital and the Diabetes Center, Key Laboratory of Diabetes Immunology, Ministry of Education, Central South University, National Clinical Research Center for Metabolic Diseases.
Second Xiangya Hospital of Central South University