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Completed

NCT Number: NCT01794429

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

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).

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Key information

Conditions

Obesity Body Weight Drug-induced Obesity Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Metabolic Syndrome Metabolic Syndrome X Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cnsr/Cins

Glostrup Municipality, 2600, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exenatide

Drug

Subcutaneum injection of exenatide once-weekly for 3 months

Other names: Bydureon

Placebo

Drug

Subcutaneum injection of placebo once-weekly for 3 months

Primary outcomes

  1. Weight loss

    Time frame: 3 months

    The primary endpoint is weight loss after 3 months of treatment with a GLP-1 analogue.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Bjorn H. Ebdrup

Other

Registry information

Acronym: TAO

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 18, 2013
Registry last updated
Jun 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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