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

Primary Purpose

Obesity, Metabolic Syndrome X, Drug-induced Obesity

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Exenatide
Placebo
Sponsored by
Bjorn H. Ebdrup
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, The Metabolic Syndrome/disturbances, Drug-induced adipositas, Schizophrenia, GLP-1 analogue, cerebral effects

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cnsr/Cins

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

exenatide

Arm Description

Subcutaneum injection of placebo once-weekly for 3 months

Subcutaneum injection of exenatide once-weekly for 3 months

Outcomes

Primary Outcome Measures

Weight loss
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
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.

Full Information

First Posted
February 14, 2013
Last Updated
June 23, 2015
Sponsor
Bjorn H. Ebdrup
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1. Study Identification

Unique Protocol Identification Number
NCT01794429
Brief Title
Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue
Acronym
TAO
Official Title
Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bjorn H. Ebdrup

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolic Syndrome X, Drug-induced Obesity, Schizophrenia
Keywords
Obesity, The Metabolic Syndrome/disturbances, Drug-induced adipositas, Schizophrenia, GLP-1 analogue, cerebral effects

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subcutaneum injection of placebo once-weekly for 3 months
Arm Title
exenatide
Arm Type
Active Comparator
Arm Description
Subcutaneum injection of exenatide once-weekly for 3 months
Intervention Type
Drug
Intervention Name(s)
Exenatide
Other Intervention Name(s)
Bydureon
Intervention Description
Subcutaneum injection of exenatide once-weekly for 3 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneum injection of placebo once-weekly for 3 months
Primary Outcome Measure Information:
Title
Weight loss
Description
The primary endpoint is weight loss after 3 months of treatment with a GLP-1 analogue.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Effects of GLP-1-analogue treatment on body fat composition
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pelle L Ishøy, MD
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cnsr/Cins
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
28260235
Citation
Ishoy PL, Fagerlund B, Broberg BV, Bak N, Knop FK, Glenthoj 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.
Results Reference
derived
PubMed Identifier
27717222
Citation
Ishoy PL, Knop FK, Broberg BV, Bak N, Andersen UB, Jorgensen NR, Holst JJ, Glenthoj 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. Erratum In: Diabetes Obes Metab. 2018 May;20(5):1327-1328.
Results Reference
derived
PubMed Identifier
24401727
Citation
Ishoy PL, Knop FK, Broberg BV, Baandrup L, Fagerlund B, Jorgensen NR, Andersen UB, Rostrup E, Glenthoj 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.
Results Reference
derived

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

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