- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02306005
Insulin Therapy and Lipoproteins' Profile in Type 1 Diabetes. (InLipoDiab1)
Insulin Therapy and Quantitive and Qualitive Changes of Plasma Lipoproteins in Patients With Newly Diagnosed Type 1 Diabetes.
The aim of the study is to evaluate the effect of insulin therapy in patients with newly diagnosed type 1 diabetes on quantitative and qualitative changes of plasma lipoproteins, with particular emphasis on HDL metabolism, and analysis of the factors determining the effect of insulin therapy on lipid profile.The study is planned to cover a minimum of 100 people with newly diagnosed type 1 diabetes and lead prospective observation of this group (for a minimum of 5-10 years). Patients will be assessed: during the first hospitalization in the moment of diagnosis (prior to introduction of insulin treatment), after 3 weeks, after 6 months and after 12 months of insulin therapy. Further observations planned in the annual intervals. In addition, the study group will be under constant monitoring of metabolic evaluation every three months in the Outpatient Clinic.
During each follow-up will be assessed parameters evaluating the metabolism of plasma lipoprotein fractions and subfractions of HDL:
- The concentration of apolipoprotein: including A-I, A-II, A-IV, C (II and III), D and E
- Electrophoresis of plasma lipoproteins
- Electrophoresis of HDL
The activity of enzymes: acyltransferase lecithin: cholesterol (LCAT) and plasma lipoprotein lipase Moreover, evaluation of factors which may potentially modify the relation between insulin therapy and lipoproteins will be assessed
- Anthropometric data and markers of insulin resistance (such as BMI, waist-hip ratio, the estimated rate of glucose distribution, VAI index, body fat, blood pressure),
- Metabolic management of diabetes,,
- Protein glycation end products
- The concentration of plasma adipokines.
Expected impact of the research project on the development of science, civilization and society The obtained results allow to assess the impact of exogenous insulin on quantitative and qualitative changes and metabolism of lipoproteins in the serum of patients with type 1 diabetes. Understanding the etiopathogenesis of this phenomenon and the factors affecting it seem to be very important in the treatment of patients with type 1 diabetes, where insulin is the treatment of choice and dosage adjustment appears to be extremely important. Remains unknown whether the changes in the lipoprotein profile result from the beginning of insulin therapy or other factors influence it. Selecting a group of patients with less favorable lipoprotein profile may allow better metabolic control, and thus will affect the quality and length of life of our patients. These studies will assess the impact of our therapeutic actions on the diagnosis of the disease on long-term consequences, such as the development of chronic complications.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Aleksandra Uruska, PhD
- Número de teléfono: +48 607620750
- Correo electrónico: aleksandrauruska@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Dorota Zozulinska-Ziolkiewicz, Prof
- Número de teléfono: +48 618474579
- Correo electrónico: kldiab@raszeja.poznan.pl
Ubicaciones de estudio
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Poznan, Polonia, 60-834
- Reclutamiento
- Department of Internal Medicine and Diabetiology Poznan University of Medical Sciences
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Contacto:
- Aleksandra Uruska, PhD
- Número de teléfono: +48 607620750
- Correo electrónico: aleksandrauruska@gmail.com
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Contacto:
- Dorota Zozulinska-Ziolkiewicz, Prof
- Número de teléfono: +48 618474579
- Correo electrónico: kldiab@raszeja.poznan.pl
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- New onset type 1 diabetes and treatment with insulin.
- Written consent to participate in the study.
- There are no other medical conditions, and with no other additional drugs beyond insulin
Exclusion Criteria:
- any other medical conditions, and any other additional drugs beyond insulin
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Solo caso
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
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Type 1 diabetic patients
Newly diagnosed diabetes type 1 admitted to the Department of Internal Medicine and Diabetology.
Measurement of lipid profile and lipoproteins before and after administration of insulin.
Further continuous observation with follow-up every year and evaluation of final end-points after 5 and 10 years.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Changes in lipoproteins' metabolism
Periodo de tiempo: Change from Baseline in lipoproteins' metabolism at 6 and 12 months
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Evaluation of HDL levels, subfractions and enzymes connected with HDL metabolism (LCAT, lipoprotein lipase)
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Change from Baseline in lipoproteins' metabolism at 6 and 12 months
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Factors influencing relationship between insulin treatment and lipoproteins
Periodo de tiempo: 1 year
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Metabolic control, presence of remission, insulin resistance, adipokines, daily insulin requirement
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1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Changes in apolipoproteins
Periodo de tiempo: Change from baseline in apolipoproteins' at 6 and 12 months
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Evaluation of apolipoproteins: A-I, A-II, A-IV, C (II i III), D i E
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Change from baseline in apolipoproteins' at 6 and 12 months
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Presence of insulin resistance
Periodo de tiempo: 1 year
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Evaluation of lipid tissue content, VAI, triglycerides/HDL ratio and estimated glucose disposal rate
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1 year
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Development of Retinopathy
Periodo de tiempo: 1 year
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Evaluation of retinopathy (ophthalmology assessment)
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1 year
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Development of Neuropathy
Periodo de tiempo: 1 year
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Evaluation of presence of neuropathy peripheral and autonomic (clinical examination and ProsciCard)
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1 year
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Development of Diabetic kidney disease
Periodo de tiempo: 1 year
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Evaluation of presence of diabetic kidney disease (albuminuria, GFR)
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1 year
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Cieluch A, Uruska A, Grzelka-Wozniak A, Niedzwiecki P, Flotynska J, Zozulinska-Ziolkiewicz D. Changes in high-density lipoprotein cholesterol (HDL-C) level and the ratio of triglycerides to HDL-C during the first year of type 1 diabetes. Pol Arch Intern Med. 2019 Sep 30;129(9):598-604. doi: 10.20452/pamw.14920. Epub 2019 Aug 5.
- Cieluch A, Uruska A, Grzelka A, Zozulinska-Ziolkiewicz D. An increase in high-density lipoprotein cholesterol concentration after initiation of insulin treatment is dose-dependent in newly diagnosed type 1 diabetes. The results of the InLipoDiab1 study. Pol Arch Intern Med. 2018 Jan 31;128(1):69-71. doi: 10.20452/pamw.4183. Epub 2018 Jan 19. No abstract available.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PoznanUMS
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