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

Obesity Clinical Trial

— TAO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01794429
• Other study ID #: EudraCT nr: 2012-005404-17
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2013
• Last updated: June 23, 2015
• Start date: February 2013
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of HealthDenmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age: 18 - 65 years

• Diagnosis of the schizophrenia spectrum (ICD-10: F20.x, F25.x)both in-patients and out-patients will be included

• Current and unchanged treatment with at least one antipsychotic drug (FGA and/or SGA and/or depot treatment)

• BMI =30 kg/m2

• HbA1c < 6,5 %

Exclusion Criteria:

• Substance dependence (ICD-10: F1x.2 (apart from nicotine addiction F17.2))

• Diabetes or HbA1c =6.5%

• Contraindications to MRI (metal implants, pacemakers, severe claustrophobia, =150 kg (max. bed weight in the MRI scanner))

• Previous head trauma with a loss of consciousness for more than 5 minutes

• Pregnancy (screened by urine human chorionic gonadotropin (hCG),lactation or no acceptance to use effective contraception during the intervention period

• Severe somatic disease, including inflammatory bowel disease and chronic ketoacidosis

• Allergy to exenatide

• Coercive measures according the Danish Law of Psychiatry

• conditions that according to sponsor are not congruous with participation in the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Exenatide
Subcutaneum injection of exenatide once-weekly for 3 months
• Placebo
Subcutaneum injection of placebo once-weekly for 3 months

Locations

Country	Name	City	State
Denmark	Cnsr/Cins	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Bjorn H. Ebdrup

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	The primary endpoint is weight loss after 3 months of treatment with a GLP-1 analogue.	3 months	No
Secondary	Effects of GLP-1-analogue treatment on body fat composition	The investigators will explore potential effects of GLP-1 analogue treatment on different peripheral metabolic parameters: mainly changes in body fat composition (measured by DEXA-scan) and effects on HbA1c, triglycerides and cholesterol.	3 months	No