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

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ClinicalTrials.gov Identifier: NCT01794429

Recruitment Status : Completed

First Posted : February 18, 2013

Last Update Posted : June 24, 2015

Sponsor:

Information provided by (Responsible Party):

Bjorn H. Ebdrup, University of Copenhagen

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Obesity Metabolic Syndrome X Drug-induced Obesity Schizophrenia	Drug: Exenatide Drug: Placebo	Phase 3

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 Design


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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Schizophrenia

Drug Information available for: Exenatide

Genetic and Rare Diseases Information Center resources: Abdominal Obesity Metabolic Syndrome

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Weight loss [ Time Frame: 3 months ]
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 ]
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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

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

Locations


Denmark
Cnsr/Cins
Glostrup, Denmark, 2600

Sponsors and Collaborators

Bjorn H. Ebdrup

Investigators


Principal Investigator:	Pelle L Ishøy, MD	University of Copenhagen

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ishøy PL, Fagerlund B, Broberg BV, Bak N, Knop FK, Glenthøj BY, Ebdrup BH. No cognitive-enhancing effect of GLP-1 receptor agonism in antipsychotic-treated, obese patients with schizophrenia. Acta Psychiatr Scand. 2017 Jul;136(1):52-62. doi: 10.1111/acps.12711. Epub 2017 Mar 5.

Ishøy PL, Knop FK, Broberg BV, Bak N, Andersen UB, Jørgensen NR, Holst JJ, Glenthøj BY, Ebdrup BH. Effect of GLP-1 receptor agonist treatment on body weight in obese antipsychotic-treated patients with schizophrenia: a randomized, placebo-controlled trial. Diabetes Obes Metab. 2017 Feb;19(2):162-171. doi: 10.1111/dom.12795. Epub 2016 Nov 14.

Ishøy PL, Knop FK, Broberg BV, Baandrup L, Fagerlund B, Jørgensen NR, Andersen UB, Rostrup E, Glenthøj BY, Ebdrup BH. Treatment of antipsychotic-associated obesity with a GLP-1 receptor agonist--protocol for an investigator-initiated prospective, randomised, placebo-controlled, double-blinded intervention study: the TAO study protocol. BMJ Open. 2014 Jan 8;4(1):e004158. doi: 10.1136/bmjopen-2013-004158.


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

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