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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00528359
First Posted: September 12, 2007
Last Update Posted: March 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  Purpose
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
Schizophrenia 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
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

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).
  Eligibility

Information from the National Library of Medicine

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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)
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00528359     History of Changes
Other Study ID Numbers: AAD-001
First Submitted: September 11, 2007
First Posted: September 12, 2007
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