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Die klinische Studie NCT05498974 für Typ-1-Diabetes, Diabetes ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
China Diabetes Type 1 Study (CD1S) by China Alliance for Type 1 Diabetes 20.000 Pädiatrisch Jugendliche
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT05498974 ist eine beobachtungsstudie zur Untersuchung von Typ-1-Diabetes, Diabetes und hat den Status offene rekrutierung. Die Studie startete am 1. Januar 2022 und soll 20.000 Teilnehmer aufnehmen. Durchgeführt von Second Xiangya Hospital of Central South University ist der Abschluss für 31. Dezember 2035 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 12. August 2022 aktualisiert.
Kurzbeschreibung
The aim of the China Diabetes Type 1 Study (CD1S) is to conduct a nationwide type 1 diabetes (T1D) registry study in patients with T1D and in pediatric adolescent patients with diabetes who had an age of onset <= 20 years.
CD1S compromises a retrospective study enrolling inpatients hospitalized from Jan 1st, 2016 to Dec 31, 2021, and a prospective study beginning from the year 2022.
Ausführliche Beschreibung
The aim of the China Diabetes Type 1 Study (CD1S) is to conduct a nationwide type 1 diabetes (T1D) registry study to investigate the demographic characteristics, metabolic control, complications occurrence as well as risk factors of patients with T1D, and to investigate the clinical features, complications' burdens and risk factors in pediatric adolescent patients with diabetes who had an age of onset <= 20 years.
Offizieller Titel
China Diabetes Type 1 Study (CD1S) by China Alliance for Type 1 Diabetes
Erkrankungen
Typ-1-DiabetesDiabetesWeitere Studien-IDs
- CD1S
NCT-Nummer
Studienbeginn (tatsächlich)
2022-01-01
Zuletzt aktualisiert
2022-08-12
Studienende (vorauss.)
2035-12-31
Geplante Rekrutierung
20.000
Studientyp
Beobachtungsstudie
Status
Offene Rekrutierung
Stichwörter
Type 1 diabetes; Diabetes in Young
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Individuals diagnosed with type 1 diabetes All patients diagnosed with type 1 diabetes of all ages. | Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center |
Individuals with diabetes who had an age of onset <= 20 years. All patients with diabetes who had an age of onset \<= 20 years. | Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Change in serum hemoglobin A1c level | A1c reflects the average blood glucose level | Every year for up to 10 years |
Albumin-to-creatinine ratio in urine sample | Albumin-to-creatinine ratio in urine sample | up to 10 years |
Arteriosclerotic cardiovascular diseases | Incident cases of cardiovascular diseases | up to 10 years |
Electromyography | value of nerve conduction velocity, F wave index, H-reflex | up to 10 years |
PHQ-9 | PHQ-9（a score between 0-27, ≥10 may indicate depression) | up to 10 years |
GAD-7 | GAD-7(a score between 0-21, ≥5 may indicate general anxiety) | up to 10 years |
WHO-5 | WHO-5 (a score between 0-100, higher score means better outcome) | up to 10 years |
PAID | PAID (a score between 0-100, ≥40 warrants special attention). | up to 10 years |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Change in C-peptide | C-peptide are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study | Every year for up to 10 years |
Change in titer of autoantibodies | Glutamic acid decarboxylase antibody | Every year for up to 10 years |
Fasting blood glucose | the blood sugar level after fasting for eight hours | Every year for up to 10 years |
Systolic blood pressure | Systolic blood pressure | Every year for up to 10 years |
Diastolic blood pressure | Diastolic blood pressure | Every year for up to 10 years |
Change in lipid profiles | Including triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol | Every year for up to 10 years |
Metabolomics | un-targeted metabolomics | Every year for up to 10 years |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Zugelassene Geschlechter
Alle
1. Patients with type 1 diabetes mellitus of any duration; meeting criteria (1) or any of (2) or any of (3)
- Clinical diagnosis of type 1 diabetes by a specialist
- Age at onset < 15 years; no overweight or obesity at onset; previous diabetic ketoacidosis; highest random C-peptide < 200 pmol/L
- Initiation and continuation of insulin therapy (except pancreatic or islet transplantation) after diagnosis; positive islet autoantibodies Or 2. Children and adolescents with diabetes mellitus at age of onset <= 20 years, regardless of type and duration of disease.
For enrolment of patients with T1D, exclusion was made if any of the following criteria were met (not applicable to those with onset under 20 years of age)
No insulin dependence for at least 6 months after diagnosis of diabetes mellitus.
- No DKA for 1 month off insulin for those with a history of diabetes > 1 year. ③ C-peptide > 800 pmol/L at any time point.
Second Xiangya Hospital of Central South UniversityVerantwortliche Partei
Zhiguang Zhou, Hauptprüfer, Director, National Clinical Research Center for Metabolic Diseases, Second Xiangya Hospital of Central South University
Zentrale Studienkontakte
Kontakt: Zhiguang Zhou, MD, PhD, +8673185292154, [email protected]
Kontakt: Xia Li, MD, PhD, [email protected]
11 Studienstandorte in 1 Ländern
Gansu
Gansu Provincial People's Hospital, Lanzhou, Gansu, China
Jing Liu, Kontakt
Offene Rekrutierung
Guangdong
Shenzhen Second People's Hospital, Shenzhen, Guangdong, China
Dewen Yan, Kontakt
Offene Rekrutierung
Hainan
Hainan General Hospital, Haikou, Hainan, 570311, China
Huibiao Quan, Kontakt
Offene Rekrutierung
Heilongjiang
the First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China
Hongyu Kuang, Kontakt
Offene Rekrutierung
Henan
The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, China
Hongwei Jiang, Kontakt
Offene Rekrutierung
Hunan
The Second Xiangya Hospital, Central South University, Changsha, Hunan, 410000, China
Xia Li, MD, PhD, Kontakt, [email protected]
Offene Rekrutierung
Jiangsu
The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China
Tao Yang, Kontakt
Noch nicht rekrutierend
Shanxi
Heji Hospital Affiliated to Changzhi Medical College, Changzhi, Shanxi, China
Xiaohong Niu, Kontakt
Offene Rekrutierung
Xinjiang
The First Affiliated Hospital of Xinjiang Medical University, Ürümqi, Xinjiang, 830017, China
Sheng Jiang, Kontakt
Offene Rekrutierung
Yunnan
The First People's Hospital of Yunnan, Kunming, Yunnan, China
Heng Su, Kontakt
Offene Rekrutierung
Zhejiang
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China
Xiaohong Wu, Kontakt
Offene Rekrutierung