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Cohort Study of Patients With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT03610984
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Zhiguang Zhou, Second Xiangya Hospital of Central South University

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.

Condition or disease Intervention/treatment
Type 1 Diabetes Mellitus Structured Education Other: type 1 diabetes structured education

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cohort Study of Patients With Type 1 Diabetes:Clarifing the Underlying Hereditary and Autoimmune Pathogenic Factors
Actual Study Start Date : October 1, 2016
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
type 1 diabetes patients
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610984


Locations
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China, Hunan
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University Recruiting
Changsha, Hunan, China, 410011
Contact: Zhiguang Zhou, MD/PhD    86-731-85292154    zhouzg@hotmail.com   
Sponsors and Collaborators
Second Xiangya Hospital of Central South University

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Responsible Party: 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
ClinicalTrials.gov Identifier: NCT03610984     History of Changes
Other Study ID Numbers: T1D Cohort Study
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases