NCT01794429

Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Bjorn H. Ebdrup · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To examine if 3 months of treatment with a GLP-1 (glucagon-like-peptide-1) analogue can induce weight loss in obese, non-diabetic patients with a diagnosis within the schizophrenic spectrum. The investigators will also examine possible associations between GLP-1 treatment and peripheral metabolic parameters such as change in body fat and HbA1c. Moreover, the GLP-1 analogue treatment will be associated with the effects/changes on cognition and subjective quality of life. Possible cerebral effects (pro-cognitive) of the GLP-1 analogue treatment will associated and correlated with changes in the brain, functional magnetic resonance imaging (fMRI).

Detailed description

The primary endpoint is weight loss after 3 months of treatment with the GLP-1 analogue exenatide (Bydureon®). Secondary endpoints comprise both physiological/metabolic parameters and cognitive measurements: * Metabolic endpoints include amongst others: changes in body fat (DEXA-scan) and changes of the HbA1c(average blood glucose levels), cholesterol and triglycerides. Moreover physiological effects will be examined eg possible effect on central/peripheral bloodpressure and heart rate. * Cerebral endpoints will be investigated via functional magnetic resonance imaging (fMRI); including potential neuroprotective effects of exenatide. The main focus is potential hippocampal volume changes and potential changes in cerebral blood flow. Functional MRI will provide this data and the images will be correlated to both cognitive tests and questionnaires. * Cognitive endpoints comprise potential improvements in cognition with focus on specific memory tests (BACS, DART and Rey's Complex Figure) and possible improvements in subjective quality of life (questionnaires).

Conditions

• Obesity
• Metabolic Syndrome X
• Drug-induced Obesity
• Schizophrenia

Interventions

Type	Name	Description
DRUG	Exenatide	Subcutaneum injection of exenatide once-weekly for 3 months
DRUG	Placebo	Subcutaneum injection of placebo once-weekly for 3 months

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2013-02-18
• Last updated: 2015-06-24

Locations

1 site across 1 country: Denmark