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The Antiatherogenic Properties of HDL in Psychiatric Patients With and Without Antipsychotic Therapy

19. februar 2013 opdateret af: Osamah Hussein, Ziv Hospital

Background:

Among individuals with schizophrenia, there is an increased prevalence of obesity, dyslipidemia ,diabetes mellitus and related conditions such as cardiovascular disease. People with severe mental illnesses, such as schizophrenia, depression or bipolar disorder, have worse physical health and reduced life expectancy compared to the general population. Number of epidemiological studies of patients with schizophrenia have documented a higher incidence of cardiovascular disease than in the general population, and patients with schizophrenia may be at an elevated risk for cardiovascular disease even in the absence of antipsychotic treatment.

Affinity for the H1 receptor is most closely linked to increased weight gain, although affinity for D2, 5-HT1A, 5-HT2C and a2-receptors may also be involved. Drug affinity for the H1, M3 and 5-HT2C receptors is correlated with an increased risk of diabetes.

High-density lipoprotein cholesterol (HDL-C) concentration in the blood is independently and inversely associated with an increased risk of cardiovascular disease(CVD). However many patients with 'normal' or even 'elevated' plasma HDL experience clinical events. HDL may not always be atheroprotective and in some conditions, it paradoxically enhances the process of atherosclerosis. In addition to its role in reverse cholesterol transport, HDL shows many other protective properties towards atherosclerosis. HDL inhibits the chemotaxis of monocytes , prevents endothelial dysfunction and apoptosis, prohibit slow-density lipoprotein (LDL ) oxidation, and stimulates the proliferation of endothelial cells and smooth muscle cells. These anti-inflammatory, antioxidative, antiaggregatory, anti-coagulant, and pro-fibrinolytic activities are exerted by different components of HDL

Aim of the study:

To investigate the functional properties of HDL in psychiatric patients before and during antipsychotic therapy.

Patients and methods:

The blood will be drawn at baseline before the initiation of antipsychotic drugs and 2 months under the antipsychotic treatment.

Study procedures:

Full lipid profile including triglycerides, LDL-C, Total cholesterol, HDL-cholesterol, apo AI, apoAII and apoB100.

Serum Paraoxanase Activity

LDL oxidation and resistance to oxidation (measured by conjugated diens formation during incubation in the presence of copper).

HDL composition: total and unesterified cholesterol, triglycerides and phospholipids, TBARS content before and after exposure to AAPH as a major indicator of oxidative stress, PON activity using phenylacetate as a substrate, apoA1and PAF.

Serum parameters e.g. Diacyl glycerol acyltransferase activity, free ApoA1 and LCAT activity.

3 [H]-Cholesterol efflux will be measured by incubating J744 macrophages with serum. Radioactivity will measured by β counter in the cell lysate and the medium.

Statistical methods:

One-way AVOVA and Student's t-test for paired samples will be used for comparison of multiple groups and paired samples, respectively. p<0.05 will be considered significant.

Studieoversigt

Status

Ukendt

Undersøgelsestype

Observationel

Tilmelding (Forventet)

20

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Safed, Israel, 13110
        • Rekruttering
        • Ziv Medical Center (Government Hospital)
        • Ledende efterforsker:
          • Osamah Hussein, MD
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

psychiatric patients before and during antipsychotic therapy

Beskrivelse

Inclusion Criteria:

  • in patients and outpatients with schizophrenia, schizoaffective and bipolar disorder based on psychiatrist diagnostic evaluation using DSM-IV criteria, before and at least two months after antipsychotic therapy will be enrolled.

Exclusion Criteria:

  • Unwillingness to participate in the study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
psychiatric patients
20 in patients and outpatients with schizophrenia, schizoaffective and bipolar disorder based on psychiatrist diagnostic evaluation using DSM-IV criteria, before and at least two months after antipsychotic therapy will be enrolled.
healthy volunteers

Ten healthy volunteers will be checked as controls:

Employee from the hospital staff with no metabolic disease (Diabetes mellitus, hypertension or dyslipidemia) and non-smokers.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2010

Primær færdiggørelse (Forventet)

1. december 2014

Datoer for studieregistrering

Først indsendt

4. oktober 2010

Først indsendt, der opfyldte QC-kriterier

5. oktober 2010

Først opslået (Skøn)

6. oktober 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. februar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. februar 2013

Sidst verificeret

1. februar 2013

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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