Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue (TAO)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01794429 |
Recruitment Status
:
Completed
First Posted
: February 18, 2013
Last Update Posted
: June 24, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
---|---|---|
Obesity Metabolic Syndrome X Drug-induced Obesity Schizophrenia | Drug: Exenatide Drug: Placebo | Phase 3 |
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 (Clinical Trial) |
Actual Enrollment : | 45 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue |
Study Start Date : | February 2013 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | June 2015 |

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 Name: Bydureon
|
- Weight loss [ Time Frame: 3 months ]The primary endpoint is weight loss after 3 months of treatment with a GLP-1 analogue.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794429
Denmark | |
Cnsr/Cins | |
Glostrup, Denmark, 2600 |
Principal Investigator: | Pelle L Ishøy, MD | University of Copenhagen |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
First Posted: | February 18, 2013 Key Record Dates |
Last Update Posted: | June 24, 2015 |
Last Verified: | June 2015 |
Keywords provided by Bjorn H. Ebdrup, University of Copenhagen:
Obesity The Metabolic Syndrome/disturbances Drug-induced adipositas |
Schizophrenia GLP-1 analogue cerebral effects |
Additional relevant MeSH terms:
Obesity Schizophrenia Metabolic Syndrome X Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Insulin Resistance Hyperinsulinism |
Glucose Metabolism Disorders Metabolic Diseases Antipsychotic Agents Exenatide Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Hypoglycemic Agents Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |