Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue
NCT01794429 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2015-06-24
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).
Conditions
- Obesity
- Metabolic Syndrome X
- Drug-induced Obesity
- Schizophrenia
Interventions
- DRUG
-
Exenatide
Subcutaneum injection of exenatide once-weekly for 3 months
- DRUG
-
Subcutaneum injection of placebo once-weekly for 3 months
Sponsors & Collaborators
-
Bjorn H. Ebdrup
lead OTHER
Principal Investigators
-
Pelle L Ishøy, MD · University of Copenhagen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-02-28
- Primary Completion
- 2015-06-30
- Completion
- 2015-06-30
Countries
- Denmark
Study Locations
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