Clinical trial NCT03610984: Cohort Study of Patients With Type 1 Diabetes
Official title: Cohort Study of Patients With Type 1 Diabetes：Clarifing the Underlying Hereditary and Autoimmune Pathogenic Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Structured Education
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 2110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: type 1 diabetes patients

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.


Eligibility criteria: Inclusion Criteria:

1. diabetes diagnosed according to the report of WHO (World Health Organization) in 1999;
2. insulin dependence from disease onset,thus diagnosed with type 1 diabetes;
3. 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:

1. secondary diabetes mellitus;
2. pregnant women;
3. malignant disease.

Primary outcomes:
measure: Effects of structured education on β-cell endocrine function progression of T1D patients.
timeFrame: Baseline and every three months afterwards.
Secondary outcomes:
measure: Effects of structured education on blood sugar control.
timeFrame: Baseline and every three months afterwards.
measure: Effects of structured education on blood sugar control.
timeFrame: Baseline and every three months afterwards.
measure: Effects of structured education on blood sugar control.
timeFrame: Baseline and every three months afterwards.
measure: Effects of structured education on metabolic control.
timeFrame: Baseline and every three months afterwards.
measure: Effects of structured education on metabolic control.
timeFrame: Baseline and every three months afterwards.
measure: Effects of structured education on metabolic control.
timeFrame: Baseline and every three months afterwards.
Other outcomes:
Locations:
city: Changsha
country: China
facility: Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
state: Hunan
Study officials:
References:
citation: Chen Y, Xia Y, Xie Z, Zhong T, Tang R, Li X, Zhou Z. The Unfavorable Impact of DR9/DR9 Genotype on the Frequency and Quality of Partial Remission in Type 1 Diabetes. J Clin Endocrinol Metab. 2022 Jan 1;107(1):e293-e302. doi: 10.1210/clinem/dgab589.
citation: Zhu S, Liu F, Li J, Guan Y, Meng M, Li X, Zhou Z, Xu R, Li L. Development and validation of a self-management scale of type 1 diabetes for Chinese adults. J Int Med Res. 2020 Aug;48(8):300060520947588. doi: 10.1177/0300060520947588.
citation: Li X, Zhong T, Tang R, Wu C, Xie Y, Liu F, Zhou Z. PD-1 and PD-L1 Expression in Peripheral CD4/CD8+ T Cells Is Restored in the Partial Remission Phase in Type 1 Diabetes. J Clin Endocrinol Metab. 2020 Jun 1;105(6):dgaa130. doi: 10.1210/clinem/dgaa130.
citation: Xie Y, Liu F, Huang F, Lan C, Guo J, He J, Li L, Li X, Zhou Z. Establishment of a type 1 diabetes structured education programme suitable for Chinese patients: type 1 diabetes education in lifestyle and self adjustment (TELSA). BMC Endocr Disord. 2020 Mar 10;20(1):37. doi: 10.1186/s12902-020-0514-9.