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- Ensaio 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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Montpellier, França, 34295
- Recrutamento
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Contato:
- Jean-Luc FAILLIE, MD PhD
- Número de telefone: +33 4 67 33 67 52
- E-mail: jl-faillie@chu-montpellier.fr
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Outro: patient with antipsychotic/neuroleptic
Blood sample performed on patients requiring the establishment of treatment with antipsychotic / neuroleptic
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Amostra de sangue
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Proportion of patients with changes from baseline cardiometabolic risk
Prazo: At 12 months
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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.
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At 12 months
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Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Proportion of patients with changes from baseline cardiometabolic risk
Prazo: At 3 months
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At 3 months
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Proportion of patients with changes from baseline cardiometabolic risk
Prazo: At 6 months
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At 6 months
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Proportion of patients with 15% increase in fasting plasma glucose
Prazo: From baseline at 12 months
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From baseline at 12 months
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Proportion of patients with 15% increase in plasma fasting insulin
Prazo: From baseline at 12 months
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From baseline at 12 months
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Proportion of patients with 15% increase in HOMA-IR [Ins (uU / mL) x Gly (mmol / L) / 22.5]
Prazo: From baseline at 12 months
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From baseline at 12 months
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Proportion of patients with 15% increase in total cholesterol levels, or LDL-cholesterol and/or reduction of 15% of HDL-cholesterol
Prazo: From baseline at 12 months
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From baseline at 12 months
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Proportion of patients with 2 points increased in BMI and/or increase of 5 cm in waist circumference
Prazo: From baseline at 12 months
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From baseline at 12 months
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9. Proportion of patients with 10 msec increase in the QTc interval of the ECG
Prazo: From baseline at 12 months
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From baseline at 12 months
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Change in zincemia
Prazo: From baseline at 12 months
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From baseline at 12 months
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Change in zincemia
Prazo: From baseline at 3 months
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From baseline at 3 months
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Change in zincemia
Prazo: From baseline at 6 months
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From baseline at 6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jean-Luc FAILLIE, MD PhD, Montpellier University Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UF 9362
- 2014-A00381-46 (Outro identificador: FRANCE: Agence Nationale de Sécurité des Médicaments)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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