- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02986490
Magnesium Variations and Cardiometabolic Risk in Patients With Antipsychotic Drugs
Influence of Magnesium Variations (Serum and Intra-erythrocyte) on Markers of Cardiometabolic Risk in Long-term Prescription of Antipsychotic Drugs: a Prospective Cohort Study
Background: Antipsychotics can induce metabolic disorders such as obesity, hyperglycemia, dyslipidemia or metabolic syndrome. It has been observed that treatment with antipsychotic could be accompanied by a decrease in the concentration of serum magnesium. Low serum concentrations of magnesium are potentially a risk factor of cardiac sudden death (Peacock, 2010). Hypotheses linking magnesium and pathogenesis of cardiovacuscular diseases are multiple. Also, it seems to exist a close relationship between magnesium and carbohydrate metabolism. Most studies on the subject have generally studied plasmatic magnesium.
Objective : Describe the relationship between changes in serum and intra-erythrocyte magnesium and cardiometabolic risk in patients innitiating an antipsychotic treatment. A secondary objective is to specify the frequency, magnitude and time to onset of changes in plasma of magnesium levels under antipsychotic treatment.
Methods : This is a pilot single-center prospective cohort. After inclusion, patients status (including magnesium levels) will be evaluated (1 and 3 months of treatment) and that status will define the exposure criterion. Included patients will be followed for 1 year during which cardiometabolic markers will be measured.
Population : patients who are more than 18 years old with schizophrenia schizoaffective disorder or bipolar disorder, naive to antipsychotic treatment or off for more than 3 months and requiring the introduction of antipsychotic drug therapy. Patients will be recruited during consultations and stays in care units of Adult Psychiatry Unit of Montpellier University Hospital.
Factor studied: serum and intra-erythrocytic magnesium levels at beginning and during the antipsychotic treatment measured by a unique analyzer center. Changes in levels of hypomagnesemia expected during the treatment will determine exposure groups.
Outcome: cardiometabolic risk markers measured at the beginning and during the treatment will be fasting blood glucose, fasting plasma insulin, HOMA-IR [Ins (uU / mL) x Gly (mmol / L) / 22.5], lipid profile (total cholesterol, LDL, HDL), BMI, waist circumference and ECG (QTc).
Cofactors: age, sex, personal and family medical history, blood pressure, smoking, diet, physical activity, psychiatric disease, Global Impressions, anti-psychotic treatment and comedications.
Perspectives : to show that decreased in magnesium levels observed among patients starting antipsychotic treatment is associated with deterioration of cardiometabolic risk markers. The demonstration of this association could explain at least part the increased cardiovascular risk observed in this population. In the longer term, the results of this study would argue the implementation of an intervention research project studying magnesium supplementation to minimize the metabolic effects of antipsychotic medications.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a pilot single-center prospective cohort. After inclusion, patients status (including magnesium levels) will be evaluated (1 and 3 months of treatment) and that status will define the exposure criterion. Included patients will be followed for 1 year during which cardiometabolic markers will be measured.
Patients will be recruited during consultations and stays in care units of Adult Psychiatry Unit of Montpellier University Hospital.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jean-Luc FAILLIE, MD PhD
- Número de teléfono: +33 4 67 33 67 52
- Correo electrónico: jl-faillie@chu-montpellier.fr
Ubicaciones de estudio
-
-
-
Montpellier, Francia, 34295
- Reclutamiento
-
Contacto:
- Jean-Luc FAILLIE, MD PhD
- Número de teléfono: +33 4 67 33 67 52
- Correo electrónico: jl-faillie@chu-montpellier.fr
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria:
- Patient with severe mental illness (schizophrenia and other disorders chronic psychotic, schizoaffective disorder and bipolar disorder.
- Patient naive to antipsychotic treatment or stopped for more than 3 months (more than 6 months for antipsychotic action extended) and requiring the introduction of antipsychotic therapy
- Patient informed and accepting the proposed follow-up (himself or his/her legal representative)
- Patient available for one year monitoring
- Patient affiliated or beneficiary of a social security insurance
Exclusion criteria:
- patient's opposition
- Pregnant or breastfeeding patient
- Patients on anti-psychotic or treatment stopped for less than 3 months (6 months for antipsychotic prolonged action)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: patient with antipsychotic/neuroleptic
Blood sample performed on patients requiring the establishment of treatment with antipsychotic / neuroleptic
|
Muestra de sangre
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Proportion of patients with changes from baseline cardiometabolic risk
Periodo de tiempo: At 12 months
|
Changes from baseline cardiometabolic risk is defined the following composite outcome : 15% increase in fasting plasma glucose and/or 15% increase in plasma fasting insulin and/or 15% increase in HOMA-IR [Ins (uU / mL) x Gly (mmol / L) / 22.5] and/or 15% increase in total cholesterol levels, or LDL-cholesterol and/or reduction of 15% of HDL-cholesterol and/or 2 points increased in BMI and/or increase of 5 cm in waist circumference and/or 10 msec increase in the QTc interval of the ECG.
|
At 12 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Proportion of patients with changes from baseline cardiometabolic risk
Periodo de tiempo: At 3 months
|
At 3 months
|
Proportion of patients with changes from baseline cardiometabolic risk
Periodo de tiempo: At 6 months
|
At 6 months
|
Proportion of patients with 15% increase in fasting plasma glucose
Periodo de tiempo: From baseline at 12 months
|
From baseline at 12 months
|
Proportion of patients with 15% increase in plasma fasting insulin
Periodo de tiempo: From baseline at 12 months
|
From baseline at 12 months
|
Proportion of patients with 15% increase in HOMA-IR [Ins (uU / mL) x Gly (mmol / L) / 22.5]
Periodo de tiempo: From baseline at 12 months
|
From baseline at 12 months
|
Proportion of patients with 15% increase in total cholesterol levels, or LDL-cholesterol and/or reduction of 15% of HDL-cholesterol
Periodo de tiempo: From baseline at 12 months
|
From baseline at 12 months
|
Proportion of patients with 2 points increased in BMI and/or increase of 5 cm in waist circumference
Periodo de tiempo: From baseline at 12 months
|
From baseline at 12 months
|
9. Proportion of patients with 10 msec increase in the QTc interval of the ECG
Periodo de tiempo: From baseline at 12 months
|
From baseline at 12 months
|
Change in zincemia
Periodo de tiempo: From baseline at 12 months
|
From baseline at 12 months
|
Change in zincemia
Periodo de tiempo: From baseline at 3 months
|
From baseline at 3 months
|
Change in zincemia
Periodo de tiempo: From baseline at 6 months
|
From baseline at 6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jean-Luc FAILLIE, MD PhD, Montpellier University Hospital
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 (Estimar)
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
- UF 9362
- 2014-A00381-46 (Otro identificador: FRANCE: Agence Nationale de Sécurité des Médicaments)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .
Ensayos clínicos sobre Muestra de sangre
-
Hillel Yaffe Medical CenterDesconocido
-
University Hospital, RouenAún no reclutandoHepatitis B | Hepatitis C | SIDAFrancia
-
Haydarpasa Numune Training and Research HospitalTerminadoDesorden sangrantePavo
-
Smiths Medical, ASD, Inc.Terminado
-
Applied Science & Performance InstituteTerminadoDeficiencia de hierro (sin anemia)Estados Unidos
-
Ischemia Care LLCTerminadoAccidente cerebrovascular isquémico | Fibrilación auricular | Accidente cerebrovascular trombótico | Ataques isquémicos transitorios | Accidente cerebrovascular cardioembólico | Accidente cerebrovascular de la arteria basilar | Eventos cerebrovasculares transitoriosEstados Unidos
-
Tan Tock Seng HospitalMayo ClinicDesconocidoSepticemia | Fungemia | Bacteriemia | Infección del torrente sanguíneoSingapur
-
University of California, IrvineNational Heart, Lung, and Blood Institute (NHLBI)ReclutamientoHipertensión | Adherencia a la medicaciónEstados Unidos
-
University Hospital, Clermont-FerrandCentre Jean PerrinDesconocidoAsincronía Ventricular IzquierdaFrancia
-
University of Maryland, BaltimoreTerminadoDeficiencia de hierro no anémicaEstados Unidos