- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05370560
Plasma Transthyretin Levels and Risk of Type 2 Diabetes Mellitus and Impaired Glucose Regulation
Plasma Transthyretin Levels and Risk of Type 2 Diabetes Mellitus and Impaired Glucose Regulation in a Chinese Population
Objective: To investigate the association between plasma transthyretin levels and risk of newly diagnosed type 2 diabetes mellitus (T2DM) and impaired glucose regulation (IGR) in a Chinese population.
Design: We performed a case-control study, including 1,244 newly diagnosed T2DM patients, 837 newly diagnosed IGR patients, and 1,244 individuals with normal glucose tolerance (NGT). The diagnostic criteria were recommended by World Health Organization in 1999. All cases were recruited from patients who, for the first time, received a diagnosis of T2DM in the Department of Endocrinology, Tongji Hospital, Tongji Medical College, Wuhan, China, from December 2010 to December 2016. Concomitantly, general population undergoing a routine health checkup in the same hospital were enrolled as controls. The inclusion criteria were age ≥ 30 years, BMI < 40 kg/m2, and no history of diagnosis of diabetes or receiving pharmacological treatment for hypertension and hyperlipidemia. Participants with clinically significant neurological, endocrinological, psychological or other systemic diseases, as well as acute illness or chronic inflammatory or infectious diseases, were excluded from the present study. Written informed consent was obtained from each participant. Besides, cases were stringently matched to controls in a 1:1 ratio, based on sex and age (± 3 years). All participants enrolled were of Han ethnicity, and gave a commitment of taking no medication known affecting glucose tolerance or insulin secretion before participating in the study. Fasting blood samples were collected in EDTA-anticoagulative tubes and separated for plasma within 1 h. Then plasma was kept at -80℃ prior to analyses. Plasma transthyretin levels were measured by BS 200 Autoanalyser (Mindray, Shenzhen, China) using immunoturbidimetric method.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
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:
- Age ≥ 30 years, BMI < 40 kg/m2, and no history of diagnosis of diabetes or receiving pharmacological treatment for hypertension and hyperlipidemia
Exclusion Criteria:
- Clinically significant neurological, endocrinological, psychological or other systemic diseases, as well as acute illness or chronic inflammatory or infectious diseases.
Incomplete basic information.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Type 2 diabetes mellitus
In this case-control study, T2DM was diagnosed according to the diagnostic criteria recommended by the WHO in 1999.
T2DM was confirmed when fasting plasma glucose (FPG) ≥ 7.0 mmol/L and/or 2-h post-glucose load (OGTT2h) ≥ 11.1 mmol/L.
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Plasma transthyretin concentrations were measured by BS 200 Autoanalyser (Mindray, Shenzhen, China) using immunoturbidimetric method.
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Impaired glucose regulation
In this case-control study, IGR was diagnosed according to the diagnostic criteria recommended by the WHO in 1999.
IGR was defined as impaired fasting glucose ([FPG] ≥ 6.1 mmol/L and < 7.0 mmol/L, and [OGTT2h] < 7.8 mmol/L) and/or impaired glucose tolerance (FPG < 7.0 mmol/L, and OGTT2h ≥ 7.8 mmol/L and < 11.1 mmol/L).
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Plasma transthyretin concentrations were measured by BS 200 Autoanalyser (Mindray, Shenzhen, China) using immunoturbidimetric method.
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Control
Those with FPG < 6.1 mmol/L and OGTT2h < 7.8 mmol/L were considered controls.
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Plasma transthyretin concentrations were measured by BS 200 Autoanalyser (Mindray, Shenzhen, China) using immunoturbidimetric method.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Type 2 diabetes mellitus
Periodo de tiempo: From December 2010 to December 2016
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In the case-control study, type 2 diabetes mellitus was diagnosed in accordance with the diagnostic criteria recommended by WHO in 1999.
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From December 2010 to December 2016
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- YR202205
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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