Trial record 4 of 1125 for:
Open Studies | "Obesity"
Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue (TAO)
This study is currently recruiting participants.
Verified February 2013 by University of Copenhagen
Sponsor:
Bjorn H. Ebdrup
Information provided by (Responsible Party):
Bjorn H. Ebdrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01794429
First received: February 14, 2013
Last updated: February 15, 2013
Last verified: February 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Obesity The Metabolic Syndrome Drug-induced Obesity Schizophrenia |
Drug: Exenatide Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue |
Resource links provided by NLM:
Further study details as provided by University of Copenhagen:
Primary Outcome Measures:
- Weight loss [ Time Frame: 3 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01794429
Contacts
| Contact: Pelle L Ishøy, MD | (0045) 2674 3184 | pelle@cnsr.dk |
| Contact: Bjørn H Ebdrup, MD PhD | (0045) 2613 3832 | bebdrup@cnsr.dk |
Locations
| Denmark | |
| Cnsr/Cins | Recruiting |
| Glostrup, Denmark, 2600 | |
| Contact: Pelle L. Ishøy, MD +45 2674 3184 pelle@cnsr.dk | |
| Contact: Bjørn H. Ebdrup, MD PhD +45 2613 3832 bebdrup@cnsr.dk | |
| Principal Investigator: Pelle L. Ishøy, MD | |
Sponsors and Collaborators
Bjorn H. Ebdrup
Investigators
| Principal Investigator: | Pelle Lau Ishøy, MD | University of Copenhagen |
More Information
No publications provided
| 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 |
| Study First Received: | February 14, 2013 |
| Last Updated: | February 15, 2013 |
| Health Authority: | Denmark: National Board of Health Denmark: The Committees on Biomedical Research Ethics for the Capital Region of Denmark Denmark: The Danish Data Protection Agency |
Keywords provided by University of Copenhagen:
|
Obesity The Metabolic Syndrome/disturbances Drug-induced adipositas |
Schizophrenia GLP-1 analogue cerebral effects |
Additional relevant MeSH terms:
|
Obesity Obesity, Morbid Schizophrenia Metabolic Syndrome X Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Schizophrenia and Disorders with Psychotic Features Mental Disorders Insulin Resistance Hyperinsulinism |
Glucose Metabolism Disorders Metabolic Diseases Antipsychotic Agents Exenatide Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Hypoglycemic Agents |
ClinicalTrials.gov processed this record on May 16, 2013