Cohort Study of Patients With Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Cohort Study of Patients With Type 1 Diabetes：Clarifing the Underlying Hereditary and Autoimmune Pathogenic Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03610984
• Other study ID #: T1D Cohort Study
• Status: Completed
• Start date: October 1, 2016
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2022
• Source: Second Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2110
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Structured Education
• Type 1 Diabetes Mellitus

Intervention

Other:
• type 1 diabetes structured education
The structured education is based on a regular outpatients visit.It is an education that integrated several diabetes related subjects,which mainly aimed at T1D self-management.

Locations

Country	Name	City	State
China	Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of structured education on ß-cell endocrine function progression of T1D patients.	The natural progression of patients' ß-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 ß-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).	Baseline and every three months afterwards.
Secondary	Effects of structured education on blood sugar control.	Patients' daily insulin dosage (U/Day) were collected at initial recruitment and each visit afterwards. And the above mentioned parameters in group 1(patients with structured education) and group2(patients without structured education) were compared.	Baseline and every three months afterwards.
Secondary	Effects of structured education on blood sugar control.	Patients' blood sugar levels were collected at initial recruitment and each visit afterwards. And the above mentioned parameters in group 1(patients with structured education) and group2(patients without structured education) were compared.	Baseline and every three months afterwards.
Secondary	Effects of structured education on blood sugar control.	Patients' HbA1c levels were collected at initial recruitment and each visit afterwards. And the above mentioned parameters in group 1(patients with structured education) and group2(patients without structured education) were compared.HbA1c concentration was tested by the Bio-Red Variant automatic measurement system.	Baseline and every three months afterwards.
Secondary	Effects of structured education on metabolic control.	Patients' body mass index (BMI) levels were collected at initial recruitment and each visit afterwards. And the above mentioned parameters in group 1(patients with structured education) and group2(patients without structured education) were compared.	Baseline and every three months afterwards.
Secondary	Effects of structured education on metabolic control.	Patients' systolic blood pressure (SBP) and diastolic blood pressure (DBP) levels were collected at initial recruitment and each visit afterwards. And the above mentioned parameters in group 1(patients with structured education) and group2(patients without structured education) were compared.	Baseline and every three months afterwards.
Secondary	Effects of structured education on metabolic control.	Patients' triglyceride (TG) and total cholesterol (TC) levels were collected at initial recruitment and each visit afterwards. And the above mentioned parameters in group 1(patients with structured education) and group2(patients without structured education) were compared.	Baseline and every three months afterwards.