Cohort Study of Patients With Type 1 Diabetes
2022년 7월 2일 업데이트: 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.
연구 개요
연구 유형
관찰
등록 (실제)
2110
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Hunan
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Changsha, Hunan, 중국, 410011
- Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
확률 샘플
연구 인구
type 1 diabetes patients
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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
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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.
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Conventional education group
Outpatients visit to endocrinologists when necessary in a conventional way.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Effects of structured education on β-cell endocrine function progression of T1D patients.
기간: Baseline and every three months afterwards.
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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.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Effects of structured education on blood sugar control.
기간: Baseline and every three months afterwards.
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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.
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Baseline and every three months afterwards.
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Effects of structured education on blood sugar control.
기간: Baseline and every three months afterwards.
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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.
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Baseline and every three months afterwards.
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Effects of structured education on blood sugar control.
기간: Baseline and every three months afterwards.
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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.
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Baseline and every three months afterwards.
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Effects of structured education on metabolic control.
기간: Baseline and every three months afterwards.
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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.
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Baseline and every three months afterwards.
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Effects of structured education on metabolic control.
기간: Baseline and every three months afterwards.
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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.
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Baseline and every three months afterwards.
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Effects of structured education on metabolic control.
기간: Baseline and every three months afterwards.
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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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Baseline and every three months afterwards.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 10월 1일
기본 완료 (실제)
2021년 12월 31일
연구 완료 (실제)
2021년 12월 31일
연구 등록 날짜
최초 제출
2018년 5월 11일
QC 기준을 충족하는 최초 제출
2018년 7월 25일
처음 게시됨 (실제)
2018년 8월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 7월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 7월 2일
마지막으로 확인됨
2022년 7월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .