- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03610984
Cohort Study of Patients With Type 1 Diabetes
Cohort Study of Patients With Type 1 Diabetes:Clarifing the Underlying Hereditary and Autoimmune Pathogenic Factors
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Hunan
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Changsha, Hunan, Cina, 410011
- Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Effects of structured education on β-cell endocrine function progression of T1D patients.
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Effects of structured education on blood sugar control.
Lasso di tempo: 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.
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Baseline and every three months afterwards.
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Effects of structured education on blood sugar control.
Lasso di tempo: 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.
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Baseline and every three months afterwards.
|
Effects of structured education on blood sugar control.
Lasso di tempo: 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.
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Baseline and every three months afterwards.
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Effects of structured education on metabolic control.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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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Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- T1D Cohort Study
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su type 1 diabetes structured education
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Medical College of WisconsinAttivo, non reclutante
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Second Xiangya Hospital of Central South UniversityReclutamentoDiabete | Diabete di tipo 1Cina
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University of MichiganAgency for Healthcare Research and Quality (AHRQ)CompletatoDiabete, tipo 2Stati Uniti