Cohort Study of Patients With Type 1 Diabetes

July 2, 2022 updated by: Zhiguang Zhou, Second Xiangya Hospital of Central South University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410011
        • Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

type 1 diabetes patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intensive structured education group
Regular outpatient visit in every 3 months to these patients. The glucose control and diabetes complication screening will be evaluated in visit. Patients will also be evaluated by specialized psychologists, dietitians and therapists. Diabetes self-management education will be regularly exposed to patients
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.
Conventional education group
Outpatients visit to endocrinologists when necessary in a conventional way.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and every three months afterwards.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of structured education on blood sugar control.
Time Frame: Baseline and every three months afterwards.
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.
Effects of structured education on blood sugar control.
Time Frame: Baseline and every three months afterwards.
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.
Effects of structured education on blood sugar control.
Time Frame: Baseline and every three months afterwards.
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.
Effects of structured education on metabolic control.
Time Frame: Baseline and every three months afterwards.
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.
Effects of structured education on metabolic control.
Time Frame: Baseline and every three months afterwards.
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.
Effects of structured education on metabolic control.
Time Frame: Baseline and every three months afterwards.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Xiangya Hospital of Central South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

May 11, 2018

First Submitted That Met QC Criteria

July 25, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

July 6, 2022

Last Update Submitted That Met QC Criteria

July 2, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T1D Cohort Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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