Janssen - Glucose Regulation/Risp/Olanz
Glucose Regulation During Risperidone and Olanzapine Treatment
Abnormalities in peripheral glucose regulation and type 2 diabetes can occur more commonly in individuals with schizophrenia than in healthy subjects or in other psychiatric conditions. Antipsychotic treatment may contribute significantly to abnormalities in glucose regulation. Hyperglycemia can contribute to long-term cardiovascular disease risk that may already be increased in patients with schizophrenia due to higher rates of smoking, sedentary life style, obesity and under-treated hypertension and dyslipidemia. This project will characterize the effects on glucose control of the two most commonly prescribed newer antipsychotic medications, risperidone and olanzapine, in patients with schizophrenia.
This proposal specifically hypothesizes that olanzapine treatment will be associated with decreases in insulin sensitivity (SI), without effects on insulin secretion. Treatment-related effects on glucose effectiveness (SG) will be explored.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This proposal aims to use a well-characterized procedure, the modified Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT), to characterize the glucoregulatory effects of the two most commonly prescribed atypical antipsychotic medications, risperidone and olanzapine, in comparison to the conventional antipsychotic haloperidol. Abnormalities in peripheral glucose regulation and type 2 diabetes can occur more commonly in individuals with schizophrenia than in healthy subjects or in other psychiatric conditions. While abnormalities in glucose regulation were first reported in schizophrenia prior to the introduction of antipsychotic medications, antipsychotic treatment may contribute significantly to abnormalities in glucose regulation.
Recently, the adverse effect of antipsychotic medications on systemic glucose regulation has received increased attention as investigators noted prominent adverse glucoregulatory effects associated with certain newer antipsychotic medications. Abnormal glucose regulation and new-onset type 2 diabetes have been reported during clozapine and olanzapine treatment. Complicating the study of antipsychotic-induced changes in glucose regulation, increased adiposity can decrease insulin sensitivity, and antipsychotics can increase adiposity and body mass index (BMI). However, abnormal glucose regulation and type 2 diabetes can occur during clozapine treatment in the absence of weight gain, suggesting that changes in glucose regulation can occur independent of drug-induced increases in BMI. Consistent with this, our preliminary studies indicate that important effects of clozapine and olanzapine on glucose regulation are not accounted for by differences in BMI. This proposal will compare the effects of olanzapine, risperidone and haloperidol on well-defined measures of glucose regulation.
This proposal specifically hypothesizes that olanzapine treatment will be associated with decreases in insulin sensitivity (SI), without effects on insulin secretion. Treatment-related effects on glucose effectiveness (SG) will be explored.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Missouri
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St. Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine, Psychiatry Dept.
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients: meets DSM-IV criteria for schizophrenia, any type, or schizoaffective disorder;
- Aged 18 to 60 years;
- Able to give informed consent;
- No medication changes for 2 weeks prior to and during the period of study; 5. Patients: currently taking olanzapine, risperidone, haloperidol or another typical antipsychotic.
Exclusion Criteria:
- Controls: Axis I psychiatric disorder criteria met except for substance use disorders as below;
- Meets DSM-IV criteria for the diagnoses of substance abuse or dependence within the past six months;
- Involuntary legal status (as per Missouri law);
- The presence of any serious medical disorder that may (as confirmed by peer-reviewed literature) confound the assessment of symptoms, relevant biologic measures or diagnosis; the following conditions are currently identified: insulin- or non-insulin-dependent diabetes mellitus; any intra-abdominal or intrathoracic surgery or limb amputation within the prior 6 months; any diagnosed cardiac condition causing documented hemodynamic compromise; any diagnosed respiratory condition causing documented or clinically recognized hypoxia; pregnancy or high dose estrogens, fever, narcotic therapy, acute sedative hypnotic withdrawal, corticosteroid or spironolactone therapy, dehydration, epilepsy, endocrine disease, high-dose benzodiazepine therapy (> 25 mg/day of diazepam), or any medical condition known to interfere with glucose utilization;
- Meets DSM-IV criteria for Mental Retardation (mild or worse).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Effects of olanzapine/risperidone/haloperidol on glucose regulation.
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Medidas de resultado secundarias
Medida de resultado |
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Explore Treatment-related effects on glucose effectiveness.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: John W. Newcomer, M.D., Washington University School of Medicine and Florida Atlantic University
Publicaciones y enlaces útiles
Publicaciones Generales
- Haupt DW, Fahnestock PA, Flavin KA, Schweiger JA, Stevens A, Hessler MJ, Maeda J, Yingling M, Newcomer JW. Adiposity and insulin sensitivity derived from intravenous glucose tolerance tests in antipsychotic-treated patients. Neuropsychopharmacology. 2007 Dec;32(12):2561-9. doi: 10.1038/sj.npp.1301392. Epub 2007 Mar 21.
- Haupt DW, Luber A, Maeda J, Melson AK, Schweiger JA, Newcomer JW. Plasma leptin and adiposity during antipsychotic treatment of schizophrenia. Neuropsychopharmacology. 2005 Jan;30(1):184-91. doi: 10.1038/sj.npp.1300563.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Trastornos del metabolismo de la glucosa
- Enfermedades metabólicas
- Enfermedades del sistema endocrino
- Diabetes mellitus
- Espectro de esquizofrenia y otros trastornos psicóticos
- Diabetes Mellitus, Tipo 2
- Esquizofrenia
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Depresores del sistema nervioso central
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Antieméticos
- Agentes Gastrointestinales
- Agentes antipsicóticos
- Agentes tranquilizantes
- Drogas psicotropicas
- Inhibidores de la captación de serotonina
- Inhibidores de la captación de neurotransmisores
- Moduladores de transporte de membrana
- Agentes de serotonina
- Agentes de dopamina
- Antagonistas de serotonina
- Antagonistas de la dopamina
- Olanzapina
- Risperidona
Otros números de identificación del estudio
- Janssen IVGTT/940780
- 00-0306 (Otro identificador: Washington University HRPO)
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