Cohort Study of Patients With Type 1 Diabetes
2 juli 2022 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Observationeel
Inschrijving (Werkelijk)
2110
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
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Hunan
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Changsha, Hunan, China, 410011
- Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
type 1 diabetes patients
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Effects of structured education on β-cell endocrine function progression of T1D patients.
Tijdsspanne: 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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Effects of structured education on blood sugar control.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
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Baseline and every three months afterwards.
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Effects of structured education on metabolic control.
Tijdsspanne: 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.
Tijdsspanne: 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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Baseline and every three months afterwards.
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 oktober 2016
Primaire voltooiing (Werkelijk)
31 december 2021
Studie voltooiing (Werkelijk)
31 december 2021
Studieregistratiedata
Eerst ingediend
11 mei 2018
Eerst ingediend dat voldeed aan de QC-criteria
25 juli 2018
Eerst geplaatst (Werkelijk)
2 augustus 2018
Updates van studierecords
Laatste update geplaatst (Werkelijk)
6 juli 2022
Laatste update ingediend die voldeed aan QC-criteria
2 juli 2022
Laatst geverifieerd
1 juli 2022
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- T1D Cohort Study
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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