Comparison of Glycaemic Fluctuation and Oxidative Stress Between Two Short-term Therapies for Type 2 Diabetes (COGFOST)
19 de agosto de 2015 actualizado por: Longyi Zeng, Third Affiliated Hospital, Sun Yat-Sen University
The purpose of this study is to compare the blood glucose control, glycaemic fluctuation and oxidative stress for Type 2 Diabetes between two therapies, one is glargine combined with oral drugs and the other is continuous subcutaneous insulin injection.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
This study was a single-center, randomized, controled and prospective trial.
Type 2 diabetic patients were randomized into 2 groups (Group A and Group B).
Subjects in group A would be treated by using continuous subcutaneous insulin injection with insulin lispro, while subjects in group B would be treated by using glargine with oral drugs (metformin and gliclazide modified release tablets).
After achieving the target glucose levels by two different approaches in 3-5 days, maintain the target glucose level for 3-5 days.
Then a Medtronic dynamic blood glucose meter would be applied to the subjects for 72 hours.
The clinical data, such as demographic information, present history, past history, personal history and so on were collected in the 1st day.
In the 2nd day and the last day of the trial, the blood samples of the patient were collected for the Laboratory Measurements: Cr, uric acid, aminotransferase, lipid profiles, white blood cell count, N%, fasting plasma glucose, fasting C-peptide, insulin, HbA1c and standard meal test (0.5h-postprandial and 2h-postprandial blood glucose levels, C peptide and insulin, et al.
The parameters of b-cell function and glycemia fluctuation were calculated and then analyzed by spss 13.0.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
70
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Guangdong
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Guangzhou City, Guangdong, Porcelana, 510630
- Reclutamiento
- Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University
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Contacto:
- Zeng Longyi, Professor
- Número de teléfono: 0086-020-85252160
- Correo electrónico: zssynfmk@163.com
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Contacto:
- Lin Shuo, Doctor
- Número de teléfono: 0086-020-85253408
- Correo electrónico: littltpig@yeah.net
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Investigador principal:
- Zeng Longyi, Professor
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Sub-Investigador:
- lin Shuo, Doctor
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
25 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- investigator diagnosed type 2 diabetes( 1999 WHO diagnosis criteria).
- diagnosed as type 2 diabetes in the first time without drug therapy, or type 2 diabetes does not accept insulin in the near 3 month and duration is shorter than 10 years
- Fasting plasma glucose ( FPG ) ≥11.1mmol/L or glycated haemoglobin (HbA1c )≥9%.
- agree to participate the study and sign the informed consent.
Exclusion Criteria:
- obvious failure of heart, hepatic, kidney function.
- severe acute or chronic complications, associated diseases. or other diseases that should not use oral hypoglycemic drug.
- women in pregnancy or planning to get pregnancy.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: GROUP A
using continuous subcutaneous insulin injection with insulin lispro, Humalog, initiating with 0.5-0.8
IU/kg.
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continuous subcutaneous insulin injection( insulin lispro, Humalog) to reduce blood glucose in a certain level
Otros nombres:
|
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Experimental: GROUP B
using glargine combined with oral drugs: insulin glargine, Lantus( initiating with 0.2 IU/kg) with metformin hydrochloride, Glucophage 500mg bid and gliclazide modified release tablets, Diamicron modified release(MR) tablets 60mg qd.
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long-acting insulin injection with metformin hydrochloride, Glucophage and gliclazide modified release tablets, Diamicron MR to reduce blood glucose in a certain level
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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mean amplitude of glycemic excursions( MAGE)
Periodo de tiempo: 3-5 days after patients achieving the target glucose levels, From date of randomization, assessed up to 10 days
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a Medtronic dynamic blood glucose meter was applied to the patient for 72 hours, and MAGE is calculated according to the data.
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3-5 days after patients achieving the target glucose levels, From date of randomization, assessed up to 10 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
glycated hemoglobin A1c
Periodo de tiempo: From date of randomization until the end of study, assessed up to 15 days
|
changes of HbA1c before and after the intervention
|
From date of randomization until the end of study, assessed up to 15 days
|
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glycated albumin
Periodo de tiempo: From date of randomization until the end of study, assessed up to 15 days
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changes of glycated albumin before and after the intervention
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From date of randomization until the end of study, assessed up to 15 days
|
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fasting plasma glucose, postprandial plasma glucose (30min, 120min)
Periodo de tiempo: From date of randomization until the end of study, assessed up to 15 days
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changes of fasting and postprandial plasma glucose before and after the intervention
|
From date of randomization until the end of study, assessed up to 15 days
|
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Fasting C-peptide
Periodo de tiempo: From date of randomization until the end of study, assessed up to 15 days
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changes of Fasting C-peptide before and after the intervention
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From date of randomization until the end of study, assessed up to 15 days
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Fasting insulin
Periodo de tiempo: From date of randomization until the end of study, assessed up to 15 days
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changes of Fasting insulin before and after the intervention
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From date of randomization until the end of study, assessed up to 15 days
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Homa-β
Periodo de tiempo: From date of randomization until the end of study, assessed up to 15 days
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changes of Homa-β before and after the intervention
|
From date of randomization until the end of study, assessed up to 15 days
|
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insulin secretion-sensitivity index
Periodo de tiempo: From date of randomization until the end of study, assessed up to 15 days
|
changes of insulin secretion-sensitivity index before and after the intervention
|
From date of randomization until the end of study, assessed up to 15 days
|
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disposition index
Periodo de tiempo: From date of randomization until the end of study, assessed up to 15 days
|
changes of disposition index before and after the intervention
|
From date of randomization until the end of study, assessed up to 15 days
|
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standard deviation of glucose level
Periodo de tiempo: during three days' CGMS
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standard deviation of glucose level
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during three days' CGMS
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area under curve (AUC) when the glucose level was higher than 7.8mmol/L
Periodo de tiempo: during three days' CGMS
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AUC when the glucose level was higher than 7.8mmol/L
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during three days' CGMS
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area under curve (AUC) when the glucose level was lower than 3.9mmol/L
Periodo de tiempo: during three days' CGMS
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AUC when the glucose level was higher than 3.9mmol/L
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during three days' CGMS
|
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thiobarbituric acid reactive substance
Periodo de tiempo: From date of randomization until the end of study, assessed up to 15 days
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changes of thiobarbituric acid reactive substance before and after the intervention
|
From date of randomization until the end of study, assessed up to 15 days
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the level of blood 8-hydroxy-2-deoxyguanosine(8-OHdG)
Periodo de tiempo: From date of randomization until the end of study, assessed up to 15 days
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changes of the level of blood 8-OHdG substance before and after the intervention
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From date of randomization until the end of study, assessed up to 15 days
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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the incidence of hypoglycemia
Periodo de tiempo: From date of randomization until the end of study, assessed up to 15 days
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the incidence of hypoglycemia, defined as blood glucose lower than 3.9mmol/L
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From date of randomization until the end of study, assessed up to 15 days
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the incidence of severe hypoglycemia
Periodo de tiempo: From date of randomization until the end of study, assessed up to 15 days
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defined as hypoglycemia which need other people's help or blood glucose lower than 2.8mmol/L
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From date of randomization until the end of study, assessed up to 15 days
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Zeng Longyi, professor, Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Yang W, Lu J, Weng J, Jia W, Ji L, Xiao J, Shan Z, Liu J, Tian H, Ji Q, Zhu D, Ge J, Lin L, Chen L, Guo X, Zhao Z, Li Q, Zhou Z, Shan G, He J; China National Diabetes and Metabolic Disorders Study Group. Prevalence of diabetes among men and women in China. N Engl J Med. 2010 Mar 25;362(12):1090-101. doi: 10.1056/NEJMoa0908292.
- Hanson RL, Pratley RE, Bogardus C, Narayan KM, Roumain JM, Imperatore G, Fagot-Campagna A, Pettitt DJ, Bennett PH, Knowler WC. Evaluation of simple indices of insulin sensitivity and insulin secretion for use in epidemiologic studies. Am J Epidemiol. 2000 Jan 15;151(2):190-8. doi: 10.1093/oxfordjournals.aje.a010187.
- Reznik Y, Cohen O, Aronson R, Conget I, Runzis S, Castaneda J, Lee SW; OpT2mise Study Group. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open-label controlled trial. Lancet. 2014 Oct 4;384(9950):1265-72. doi: 10.1016/S0140-6736(14)61037-0. Epub 2014 Jul 2.
- Weng J, Li Y, Xu W, Shi L, Zhang Q, Zhu D, Hu Y, Zhou Z, Yan X, Tian H, Ran X, Luo Z, Xian J, Yan L, Li F, Zeng L, Chen Y, Yang L, Yan S, Liu J, Li M, Fu Z, Cheng H. Effect of intensive insulin therapy on beta-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicentre randomised parallel-group trial. Lancet. 2008 May 24;371(9626):1753-60. doi: 10.1016/S0140-6736(08)60762-X.
- Mu PW, Chen YM, Lu HY, Wen XQ, Zhang YH, Xie RY, Shu J, Wang MM, Zeng LY. Effects of a combination of oral anti-diabetes drugs with basal insulin therapy on beta-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes. Diabetes Metab Res Rev. 2012 Mar;28(3):236-40. doi: 10.1002/dmrr.1292.
- Zeng L, Lu H, Deng H, Mu P, Li X, Wang M. Noninferiority effects on glycemic control and beta-cell function improvement in newly diagnosed type 2 diabetes patients: basal insulin monotherapy versus continuous subcutaneous insulin infusion treatment. Diabetes Technol Ther. 2012 Jan;14(1):35-42. doi: 10.1089/dia.2011.0123. Epub 2011 Aug 30. Erratum In: Diabetes Technol Ther. 2014 Mar;16(3):193.
- Brun E, Zoppini G, Zamboni C, Bonora E, Muggeo M. Glucose instability is associated with a high level of circulating p-selectin. Diabetes Care. 2001 Sep;24(9):1685. doi: 10.2337/diacare.24.9.1685. No abstract available.
- Muggeo M, Zoppini G, Bonora E, Brun E, Bonadonna RC, Moghetti P, Verlato G. Fasting plasma glucose variability predicts 10-year survival of type 2 diabetic patients: the Verona Diabetes Study. Diabetes Care. 2000 Jan;23(1):45-50. doi: 10.2337/diacare.23.1.45.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2015
Finalización primaria (Anticipado)
1 de agosto de 2016
Finalización del estudio (Anticipado)
1 de septiembre de 2016
Fechas de registro del estudio
Enviado por primera vez
10 de agosto de 2015
Primero enviado que cumplió con los criterios de control de calidad
15 de agosto de 2015
Publicado por primera vez (Estimar)
18 de agosto de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
20 de agosto de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
19 de agosto de 2015
Última verificación
1 de agosto de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20130319c
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .