Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue (TAO)

This study is currently recruiting participants.
Verified December 2013 by University of Copenhagen
Sponsor:
Information provided by (Responsible Party):
Bjorn H. Ebdrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01794429
First received: February 14, 2013
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention Phase
Obesity
Metabolic Syndrome X
Drug-induced Obesity
Schizophrenia
Drug: Exenatide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The primary endpoint is weight loss after 3 months of treatment with a GLP-1 analogue.


Secondary Outcome Measures:
  • Effects of GLP-1-analogue treatment on body fat composition [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Subcutaneum injection of placebo once-weekly for 3 months
Drug: Placebo
Subcutaneum injection of placebo once-weekly for 3 months
Other Name: Placebo
Active Comparator: exenatide
Subcutaneum injection of exenatide once-weekly for 3 months
Drug: Exenatide
Subcutaneum injection of exenatide once-weekly for 3 months
Other Name: Bydureon

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).
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01794429

Contacts
Contact: Pelle L Ishøy, MD (0045) 2674 3184 pelle@cnsr.dk
Contact: Bjørn H Ebdrup, MD PhD (0045) 2613 3832 bebdrup@cnsr.dk

Locations
Denmark
Cnsr/Cins Recruiting
Glostrup, Denmark, 2600
Contact: Pelle L. Ishøy, MD    +45 2674 3184    pelle@cnsr.dk   
Contact: Bjørn H. Ebdrup, MD PhD    +45 2613 3832    bebdrup@cnsr.dk   
Principal Investigator: Pelle L. Ishøy, MD         
Sponsors and Collaborators
Bjorn H. Ebdrup
Investigators
Principal Investigator: Pelle L Ishøy, MD University of Copenhagen
  More Information

No publications provided

Responsible Party: Bjorn H. Ebdrup, MD PHD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01794429     History of Changes
Other Study ID Numbers: EudraCT nr: 2012-005404-17
Study First Received: February 14, 2013
Last Updated: December 20, 2013
Health Authority: Denmark: National Board of Health
Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University of Copenhagen:
Obesity
The Metabolic Syndrome/disturbances
Drug-induced adipositas
Schizophrenia
GLP-1 analogue
cerebral effects

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Schizophrenia
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Antipsychotic Agents
Exenatide
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Hypoglycemic Agents

ClinicalTrials.gov processed this record on April 17, 2014