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

This study has been completed.
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain Identifier:
First received: September 11, 2007
Last updated: March 10, 2008
Last verified: March 2008
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 Intervention
Drug: quetiapine or olanzapine or risperidone or aripiprazole

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Enrollment: 36
Study Start Date: October 2005
Study Completion Date: February 2007
Groups/Cohorts Assigned Interventions
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

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).

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

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)
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Please refer to this study by its identifier: NCT00528359

Sanatia Hospital
Brussels, Belgium, 1030
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Principal Investigator: Philippe M ORIOT, MD Université Catholique de Louvain
  More Information Identifier: NCT00528359     History of Changes
Other Study ID Numbers: AAD-001
Study First Received: September 11, 2007
Last Updated: March 10, 2008

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

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Quetiapine Fumarate
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin Antagonists
Dopamine Antagonists
Dopamine Agents processed this record on May 25, 2017