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Risks for Insulin Resistance and Metabolic Syndrome Between Major Depressive Disorder (MDD) or MDD With Psychotic Features

10. února 2017 aktualizováno: John D. Matthews, Massachusetts General Hospital

Comparative Risks for Insulin Resistance and Metabolic Syndrome (MS) Among Hospitalized Patients With Major Depressive Disorder With (MDpsy) or Without (MDD) Psychotic Features

Studies have shown that people with certain disorders have an increased risk of developing a condition called Metabolic Syndrome (MS). In this study, the investigators want to learn more about MS among people staying in the hospital for treatment of Major Depressive Disorder (MDD) and also Major Depressive Disorder with Psychotic Features (MDpsy). The investigators also want to learn more about a stress hormone called cortisol that is made in the body. Those who take part in this study will answer some questionnaires, be given some psychiatric interviews, and have some blood taken along with a urine sample.

The investigators believe that patients in the hospital with MDpsy will have higher baseline rates of MS factors, cortisol levels, dexamethasone non-suppression, and insulin resistance, compared with MDD alone.

Přehled studie

Postavení

Ukončeno

Podmínky

Detailní popis

Metabolic syndrome (MS) is a combination of medical problems that can increase the risk of heart disease and diabetes in some people. People with MS can have some or all of the following:

  • High blood glucose
  • High blood pressure
  • Abdominal obesity
  • Low levels of high-density lipoprotein (HDL) cholesterol
  • High levels of triglycerides

Some studies have shown that people with certain disorders have a greater risk for developing MS. This may be because of a combination of factors, including but not limited to the type of medications used, age, and whether or not someone smokes. This study will also aim to learn more about a naturally-occurring stress hormone called cortisol that is made in the body.

In order to measure these factors, the following things will occur:

  • administer a number of questionnaires
  • gather information from medical history
  • gather information about current psychiatric mood
  • draw blood and collect a urine sample

To study the amount of cortisol in the body, a dexamethasone suppression test (DST) will be given. This test involves taking a single 1mg pill of dexamethasone, a steroid, and numerous blood draws. Like any drug, it has some risks, however it is unlikely any side effects will occur because of the low dose administered.

Typ studie

Pozorovací

Zápis (Aktuální)

14

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02114
        • Massachusetts General Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 85 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Eligible subjects are people who are inpatient in the medical-psychiatric unit at Massachusetts General Hospital. Included subjects have working diagnosis of major depressive disorder (MDD) or major depressive disorder with psychotic features (MDpsy).

Popis

Inclusion Criteria:

  • Capable of giving informed consent
  • DSM-IV TR diagnosis of Major Depressive Disorder with (MDpsy) or without (MDD) Psychotic Features
  • Age between 18 and 85, inclusive
  • Pre-existing Hyperlipidemia, Hypertension, and Diabetes must be stable with laboratory and clinical results within acceptable range; with or without medication for three months prior to admission

Exclusion Criteria:

  • DSM-IV TR diagnosis of: schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder, organic mental disorder, substance use dependence including alcohol, that has been active within the past 6 months, acute bereavement, and psychotic disorder not elsewhere classified
  • Subjects that meet criteria for substance or alcohol dependence more recently than three months prior to entering the study
  • Subjects that meet criteria for substance or alcohol abuse more recently than four weeks prior to entering the study
  • Pregnancy
  • Unstable or inadequately treated pre-existing hyperlipidemia, hypertension, and diabetes
  • Subjects who are involuntarily committed.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Velká depresivní porucha
Major Depressive Disorder with Psychotic Features

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The primary measure is any change in fasting insulin from admission to discharge while subjects are inpatient.
Časové okno: Measure fasting insulin at two timepoints; to determine change from baseline (admission) and discharge
To preserve statistical power, we will measure insulin as a continuous variable rather than dichotomizing participants into insulin sensitive vs insulin resistant.
Measure fasting insulin at two timepoints; to determine change from baseline (admission) and discharge

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The first secondary measure is a fasting lipid panel, including fasting total cholesterol, fasting LDL, fasting HDL, and fasting triglycerides; we want to measure a change in data from admission to discharge
Časové okno: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Fasting glucose will be a separate secondary outcome measure; we want to measure a change in data from admission to discharge
Časové okno: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Waist Circumference; we want to measure a change in data from admission to discharge
Časové okno: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Waist circumference will be measured once at admission and once at discharge to determine if any changes have occurred throughout time of inpatient hospitalization
Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Urine microalbumin; we want to measure a change in data from admission to discharge
Časové okno: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
C-reactive Protein; we want to measure a change in data from admission to discharge
Časové okno: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Homocysteine; we want to measure a change in data from admission to discharge
Časové okno: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Blood pressure (supine & standing as available)
Časové okno: We will be measuring this continuously throughout inpatient hospitalization, beginning at time of admission
We will be measuring this continuously throughout inpatient hospitalization, beginning at time of admission
Cortisol; we want to measure a change in data from admission to discharge
Časové okno: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
Cortisol levels will be measured before and after a dexamethasone suppression test is administered at admission and discharge
Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Massachusetts General Hospital

Spolupracovníci

National Alliance for Research on Schizophrenia and Depression

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. ledna 2011

Primární dokončení (Aktuální)

1. září 2012

Dokončení studie (Aktuální)

1. září 2012

Termíny zápisu do studia

První předloženo

15. února 2011

První předloženo, které splnilo kritéria kontroly kvality

4. března 2011

První zveřejněno (Odhad)

8. března 2011

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. února 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. února 2017

Naposledy ověřeno

1. února 2017

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2009-P-002723

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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