Schizophrenia Clinical Trial
Official title:
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.
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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