Data

Treatment of clozapine associated obesity and diabetes with exenatide in people with schizophrenia

University of Queensland

Dataset description

Twenty-eight outpatients with schizophrenia (aged 18-64 years) were randomized to once-weekly extended-release subcutaneous exenatide or usual care for 24 weeks. The primary outcome was proportion of participants with >5% weight loss. All 28 participants completed the study; 3/14 in the exenatide group and 2/14 in the usual care group had type 2 diabetes.
Click to explore relationships graph

Related Study

Treatment of clozapine associated obesity and diabetes with exenatide in people with schizophrenia

Brief Summary

Schizophrenia has a lifetime risk of 7.2 per 1000 persons with 25-50% of people with schizophrenia failing to respond to typical and atypical antipsychotics. For these people clozapine is the gold standard treatment, however, clozapine greatly increases the risk of weight gain and type 2 diabetes (T2DM) which contribute to cardiovascular disease and premature mortality. Current interventions against antipsychotic-associated metabolic dysregulation are limited and insufficient. The mechanism of action for metabolic abnormalities associated with clz is not completely understood; however, recent pre-clinical models have shown that clozapine causes acute deficits in glucose metabolism. This occurred via suppression of glucagon-like-peptide-1 (GLP-1) levels and these defects could be overcome by treatment with a GLP-1 agonist. Exenatide, a GLP-1 agonist, is available in a once weekly injectable formulation which is practical for this population with poor adherence. Therefore, in consideration of the promising preclinical data, the use of exenatide, which is already known to improve glycaemic control and reduce body weight in subjects with and without T2DM, may represent an effective therapeutic intervention for clozapine-associated obesity and T2DM. Therefore, the present study is a 24-week investigator-initiated, parallel group, randomised, open-label pilot study designed to evaluate the acceptability of exenatide weekly and determine the preliminary clinical efficacy and tolerability of exenatide for weight loss and glycaemic control in clozapine-associated obesity and T2DM. This study also has exploratory objectives to examine the feasibility of recruitment, retention, assessment methods and implementation of this intervention for subsequent larger scale, multicenter studies.

Inclusion Criteria

  • Provision of informed consent prior to any study specific procedures Clinical diagnosis of Schizophrenia or Schizoaffective Disorder On oral clozapine for at least 18 weeks Stable body weight (defined as less than 5kg change in weight over the past 3 months before inclusion) For Arm A a) Diagnosis of Type II Diabetes Mellitus b) Current and stable therapeutic doses of oral glucose lowering agents for 3 months prior to recruitment c) BMI greater than or equal to 30kg/m2 and less than 45kg/m2 For Arm B a) BMI greater than or equal to 30kg/m2 and less than 45kg/m2

Study Type

  • Interventional

Ethics Approval

Study Protocol: Available
Data Dictionary: Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

The type of data shared will depend on the conditions of an HREC waiver, as current ethical approval does not allow for sharing of IPD.

When will data be available?

The availability of the data will depend on the conditions of an HREC waiver, as current ethical approval does not allow for sharing of IPD.

Available to whom?

Data are potentially available to: - Researchers from academic institutions Based in: - Any location Further information: All data requests will be considered by the primary sponsor and is subject to an HREC waiver, considered on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see our data sharing policy (https://ppl.app.uq.edu.au/content/4.20.06-research-data-management).

Available for what types of analyses?

The types of analyses available will depend on the conditions of an HREC waiver, as current ethical approval does not allow for sharing of IPD.