β-Cell Function in Schizophrenic Subjects on Atypical Antipsychotic drugS

NCT ID: NCT00528359

Last Updated: 2008-03-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2007-02-28

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.

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).

Conditions

Schizophrenia

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

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

quetiapine or olanzapine or risperidone or aripiprazole

Intervention Type: DRUG

Interventions

quetiapine or olanzapine or risperidone or aripiprazole

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Principal Investigators

Philippe M ORIOT, MD

Role: PRINCIPAL_INVESTIGATOR

Université Catholique de Louvain

Locations

Sanatia Hospital

Brussels, , Belgium

Countries

Belgium

Other Identifiers

AAD-001

Identifier Type: -

Identifier Source: org_study_id