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

June 23, 2015 updated by: Bjorn H. Ebdrup

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark, 2600
        • Cnsr/Cins

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Subcutaneum injection of placebo once-weekly for 3 months
Drug: Placebo
Subcutaneum injection of placebo once-weekly for 3 months
Active Comparator: exenatide
Subcutaneum injection of exenatide once-weekly for 3 months
Drug: Exenatide
Subcutaneum injection of exenatide once-weekly for 3 months
Other Names:
  • Bydureon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: 3 months
The primary endpoint is weight loss after 3 months of treatment with a GLP-1 analogue.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of GLP-1-analogue treatment on body fat composition
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bjorn H. Ebdrup

Investigators

  • Principal Investigator: Pelle L Ishøy, MD, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

February 14, 2013

First Submitted That Met QC Criteria

February 15, 2013

First Posted (Estimate)

February 18, 2013

Study Record Updates

Last Update Posted (Estimate)

June 24, 2015

Last Update Submitted That Met QC Criteria

June 23, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT nr: 2012-005404-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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