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NCT00528359 Clinical Trial

β-Cell Function in Schizophrenic Subjects on Atypical Antipsychotic drugS

Schizophrenia Clinical Trial

— SANAT  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00528359
Other study ID # AAD-001
Secondary ID
Status Completed
Phase N/A
First received September 11, 2007
Last updated March 10, 2008
Start date October 2005
Est. completion date February 2007

Study information
Verified date March 2008
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date February 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility 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, ß-blockers, antiepileptic drugs and mirtazapine)

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• quetiapine or olanzapine or risperidone or aripiprazole

Locations
Country Name City State
Belgium Sanatia Hospital Brussels

Sponsors (1)
Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

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