Magnesium Variations and Cardiometabolic Risk in Patients With Antipsychotic Drugs

NCT02986490 | Unknown

• 2 other identifiers: UF 93622014-A00381-46
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia; Schizoaffective Disorder; Bipolar Disorder

Keywords

Mental disorders; Antipsychotic agents; Magnesium; Cardiovascular risk factor; Metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with changes from baseline cardiometabolic risk

  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

Secondary Outcomes (11)

• Proportion of patients with changes from baseline cardiometabolic risk

  At 3 months

• Proportion of patients with changes from baseline cardiometabolic risk

  At 6 months

• Proportion of patients with 15% increase in fasting plasma glucose

  From baseline at 12 months

• Proportion of patients with 15% increase in plasma fasting insulin

  From baseline at 12 months

• Proportion of patients with 15% increase in HOMA-IR [Ins (uU / mL) x Gly (mmol / L) / 22.5]

  From baseline at 12 months

Study Arms (1)

patient with antipsychotic/neuroleptic

OTHER

Blood sample performed on patients requiring the establishment of treatment with antipsychotic / neuroleptic

Biological: Blood sample

Interventions

Blood sample BIOLOGICAL

Blood sample

patient with antipsychotic/neuroleptic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Unknown Facility

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder; Mental Disorders; Metabolic Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Mood Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jean-Luc FAILLIE, MD PhD

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Luc FAILLIE, MD PhD

CONTACT

+33 4 67 33 67 52; jl-faillie@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: December 8, 2016
• Study Start: September 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 8, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)