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β-Cell Function in Schizophrenic Subjects on Atypical Antipsychotic drugS (SANAT)

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ClinicalTrials.gov Identifier: NCT00528359
Recruitment Status : Completed
First Posted : September 12, 2007
Last Update Posted : March 11, 2008
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary:
The purpose of this study is to determine whether atypical antipsychotic drugs (commonly prescribed for treating schizophrenia) induce changes in anthropometry and metabolism, including alteration in insulin sensitivity and/or insulin secretion by the pancreas, when given to lean, non-diabetic, individuals who are antipsychotic drug(s)-naïve, and free of metabolic syndrome at enrollment.

Condition or disease Intervention/treatment
Schizophrenia Drug: quetiapine or olanzapine or risperidone or aripiprazole

Detailed Description:
Atypical antipsychotic drugs (AADs) induce weight gain, truncal adiposity and may engender a metabolic syndrome which may progress to IFG/IGT or DM. AADs effects in lean schizophrenic patients without metabolic syndrome are not documented, especially the relationship between weight gain and changes in insulin sensitivity (S), beta-cell function (β), and circulating adiponectin. We prospectively determined the outcome of 9-month therapy with AADs on anthropometrics, metabolism and adiponectin, including HOMA-modeling of S, β, and βxS (hyperbolic product, assessing individual β adjusted for S)in 36 schizophrenic subjects (M:F 24:12; Caucasian n=23; North-African n=12; South-Asian n=1) aged 35±9 years (mean±1SD) free of MetS (NCEP-ATPIII).

Study Type : Observational
Actual Enrollment : 36 participants
Time Perspective: Prospective
Official Title: Phase 1 Study of Insulin Sensitivity, Adjusted β-Cell Function and Adiponectin Among Lean Drug-naïve Schizophrenic Subjects Treated With Atypical Antipsychotic Drugs
Study Start Date : October 2005
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Group/Cohort Intervention/treatment
A
36 lean schizophrenic subjects free of metabolic syndrome(M:F 24:12; Caucasian n=23; North-African n=12; South-Asian n=1)aged 35±9 years
Drug: quetiapine or olanzapine or risperidone or aripiprazole




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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-55 years
  • body mass index <25.0 kg/m²
  • waist circumference <102 (men) and <88 cm (women)
  • absence of a metabolic syndrome according to NCEP ATPIII criteria
  • normoglycaemic (fasting plasma glucose levels <100 mg/dl)

Exclusion Criteria:

  • previous use of antipsychotic drugs
  • concomitant therapy with drugs known to possess an inherent potential to increase weight and/or to alter glucose metabolism (including antihistaminic drugs, glucocorticoids, β-blockers, antiepileptic drugs and mirtazapine)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528359


Locations
Belgium
Sanatia Hospital
Brussels, Belgium, 1030
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: Philippe M ORIOT, MD Université Catholique de Louvain

ClinicalTrials.gov Identifier: NCT00528359     History of Changes
Other Study ID Numbers: AAD-001
First Posted: September 12, 2007    Key Record Dates
Last Update Posted: March 11, 2008
Last Verified: March 2008

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
antipsychotic drugs
schizophrenia
β-cell function
insulin resistance

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Antipsychotic Agents
Aripiprazole
Olanzapine
Quetiapine Fumarate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators