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- Ensayo clínico NCT07711171
Efficacy and Safety of Canagliflozin in the Treatment of Type 2 Diabetes With Mild Cognitive Impairment
Efficacy and Safety of Canagliflozin in the Treatment of Type 2 Diabetes With Mild Cognitive Impairment- a Prospective, Randomized, Single-blind, Controlled, Single-center, Head-to-head Clinical Cohort Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The prevalence of cognitive dysfunction in diabetic patients is high, which seriously affects the quality of life of patients. Cognitive impairment mainly includes two stages: mild cognitive impairment (MCI) and dementia. Early detection of diabetic patients with MCI and effective intervention measures to prevent and delay the onset of dementia have important clinical value and social significance. With the development of imaging technology, especially fMRI changes in local blood flow and metabolic activities of the brain can be displayed before changes in brain structure. The central insulin resistance status observed by fMRI may serve as an alternative endpoint for assessing cognitive function. SGLT2i has been shown to significantly improve insulin resistance in the central nervous system in previous basic and clinical studies. However, up to now, no head-to-head clinical studies have been reported on SGLT2i and other antidiabetic drugs in patients with MCI.
Based on the above research background, we hypothesize that canagliflozin, as a clinically commonly used SGLT2i, it may improve cognitive function in patients with type 2 diabetes mellitus and MCI by improving insulin resistance in the central nervous system.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Bin Lu, doctor
- Número de teléfono: 18121186716
- Correo electrónico: lubinfd@126.com
Copia de seguridad de contactos de estudio
- Nombre: Cuiping Jiang, master
Ubicaciones de estudio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana
- Reclutamiento
- Fudan University affiliated Huadong Hospital
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Contacto:
- Bin Lu, doctor
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- age: 40-75 years old;
- HbA1c: 7.0 - 10.0%;
- Moca scale total score between 20-26 (duration of education is more than 10 years) or total score between 20 and 25 (duration of education is less than 10 years);
- sign informed consent;
Exclusion Criteria:
- left-handedness;
- duration of diabetes is less than 6 years;
- inability to complete central nervous system magnetic resonance imaging;
- alcohol or drug addiction history;
- use of other oral hypoglycemic drugs within 90 days prior to enrollment except for metformin;
- Family or past history of neurological or psychiatric disorders, pancreatitis, medullary thyroid cancer and multiple endocrine adenomatosis;
- History of recurrent urinary tract infection and malignant tumor;
- History of severe gastrointestinal diseases and gastroenteric surgery;
- Pregnancy/lactation status;
- Abnormal liver function (liver enzyme index is more than 2.5 times the upper limit of the reference range) or abnormal kidney function (estimated glomerular filtration rate is less than 45ml/min); Type 1 diabetes; other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the working environment and unstable living environment, which are likely to cause loss of follow-up, according to the judgment of the researchers;
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: canagliflozin treatment group
Canagliflozin was used once daily, 100 mg/time, orally
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Canagliflozin,100mg once daily, orally, for 6 months
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Comparador de placebos: sitagliptin treatment group
Sitagliptin was used 100mg once daily, orally.
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Sitagliptin,100mg once daily, orally, for 6 months
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Comparador de placebos: Acarbose treatment group
Acarbose was used 100mg three times daily, orally.
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Acarbose,100mg three times daily, orally, for 6 months
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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the changes in cerebral blood flow shown by fMRI
Periodo de tiempo: 6 months
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the changes in cerebral blood flow shown by fMRI after nasal inhalation of insulin
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Montreal Cognitive Assessment Scale (Moca scale)
Periodo de tiempo: 6 months
|
The Moca scale score ranges from 0 to 30.
The higher the score, the better the cognitive function.
Scores ranging from 12 to 21 are classified as dementia, while scores between 19 and 26 are classified as MCI.
The investigators compare the scores of the Moca scale before and after the intervention.
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6 months
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body composition
Periodo de tiempo: 6 months
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The body composition is measured using Beijing Yueqi BIA.
The indicators include weight (kg), skeletal muscle (kg), body fat (kg), body mass index (kg/m2), body fat percentage (%), visceral fat area (cm2), waist-to-hip ratio, and skeletal muscle index (kg/m2).
The investigators compare the changes in body composition before and after the intervention.
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6 months
|
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grip strength
Periodo de tiempo: 6 months
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The grip strength is evaluated using an electronic grip strength tester.
Each hand is tested twice, and the average values are taken.
The side with the greater grip strength is selected as the final grip strength.
A low grip strength is defined as less than 28 kg for men and less than 18 kg for women.
The investigators compare the changes in grip strength before and after the intervention.
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6 months
|
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glycated hemoglobin
Periodo de tiempo: 6 months
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The glycated hemoglobin (%) is measured on an empty stomach, and the investigators compare the changes before and after the intervention.
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6 months
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insulin
Periodo de tiempo: 6 months
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The measurement of insulin (mIU/L) is conducted in the fasting state.
The investigators compare the changes before and after the intervention.
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6 months
|
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C-peptide
Periodo de tiempo: 6 months
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The measurement of C-peptide (ng/ml) is conducted in the fasting state.
The investigators compare the changes before and after the intervention.
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6 months
|
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blood glucose
Periodo de tiempo: 6 months
|
The measurement of blood glucose (mmol/L) is conducted in the fasting state.
The investigators compare the changes before and after the intervention.
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6 months
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- Enfermedades del sistema endocrino
- Desordenes mentales
- Enfermedades metabólicas
- Trastornos neurocognitivos
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Trastornos cognitivos
- Enfermedades Nutricionales y Metabólicas
- Disfunción congnitiva
- Diabetes Mellitus, Tipo 2
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Azoles
- Carbohidratos
- Polisacáridos
- Oligosacáridos
- Pirazinas
- Triazoles
- Trisacáridos
- Fosfato de sitagliptina
- Acarbosa
Otros números de identificación del estudio
- 2022XD020
Plan de datos de participantes individuales (IPD)
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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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