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

This study has been completed.
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00528359
First received: September 11, 2007
Last updated: March 10, 2008
Last verified: March 2008
History of Changes
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00528359     History of Changes
Other Study ID Numbers: AAD-001
Study First Received: September 11, 2007
Last Updated: March 10, 2008
Health Authority: Belgium: Institutional Review Board

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 and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Risperidone
Quetiapine
Olanzapine
Aripiprazole
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 22, 2013