Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Magnesium Variations and Cardiometabolic Risk in Patients With Antipsychotic Drugs

5. desember 2016 oppdatert av: University Hospital, Montpellier

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.

Studieoversikt

Status

Ukjent

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: patient with antipsychotic/neuroleptic
Blood sample performed on patients requiring the establishment of treatment with antipsychotic / neuroleptic
Blodprøve

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of patients with changes from baseline cardiometabolic risk
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tidsramme
Proportion of patients with changes from baseline cardiometabolic risk
Tidsramme: At 3 months
At 3 months
Proportion of patients with changes from baseline cardiometabolic risk
Tidsramme: At 6 months
At 6 months
Proportion of patients with 15% increase in fasting plasma glucose
Tidsramme: From baseline at 12 months
From baseline at 12 months
Proportion of patients with 15% increase in plasma fasting insulin
Tidsramme: 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]
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: From baseline at 12 months
From baseline at 12 months
Change in zincemia
Tidsramme: From baseline at 12 months
From baseline at 12 months
Change in zincemia
Tidsramme: From baseline at 3 months
From baseline at 3 months
Change in zincemia
Tidsramme: From baseline at 6 months
From baseline at 6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Jean-Luc FAILLIE, MD PhD, Montpellier University Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2014

Primær fullføring (Forventet)

1. januar 2017

Studiet fullført (Forventet)

1. desember 2017

Datoer for studieregistrering

Først innsendt

8. juli 2016

Først innsendt som oppfylte QC-kriteriene

5. desember 2016

Først lagt ut (Anslag)

8. desember 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

8. desember 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. desember 2016

Sist bekreftet

1. juli 2016

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • UF 9362
  • 2014-A00381-46 (Annen identifikator: FRANCE: Agence Nationale de Sécurité des Médicaments)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Blodprøve

3
Abonnere