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Trial registered on ANZCTR
Registration number
ACTRN12610000911099
Ethics application status
Not yet submitted
Date submitted
26/10/2010
Date registered
26/10/2010
Date last updated
26/10/2010
Type of registration
Prospectively registered
Titles & IDs
Public title
The metabolic effect of antipsychotic medication
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Scientific title
The effect of antipyschotic medication in healthy volunteers on glucose metabolism and gut hormones
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Secondary ID [1]
252955
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No other ID number at this stage
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Schizophrenia
258486
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Glucose intolerance
258487
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Condition category
Condition code
Mental Health
258654
258654
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0
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Schizophrenia
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Metabolic and Endocrine
258655
258655
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
patients will be randomised to one of the four groups:
group 1:
8 days use of olanzapine 10mg daily (oral tablets)
group2:
8 days use of olanzapine 10mg daily (oral tablets) +
metformin oral tablets 1g twice a day during the same 8 day period
group 3:
8 days use of olanzapine 10mg daily (oral tablets) + sitagliptin oral tablets 100mg daily during the same 8 day period
group 4:
8 days use of olanzapine 10mg daily (oral tablets) + exenatide (subcutaneous injection) 10micrograms twice a day during the same 8 day period
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Intervention code [1]
257484
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Treatment: Drugs
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Comparator / control treatment
Olanzapine alone without additional treatment
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Control group
Active
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Outcomes
Primary outcome [1]
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post-olanzapine change in glucagon-like-peptide-1 (GLP1) and glucagon area under curve during oral glucose tolerance test compared with baseline.
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Assessment method [1]
259505
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Timepoint [1]
259505
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testing prior to 8 day treatment of olanzapine +/- one of exenatide, metformin or sitagliptin. testing again after 8 days teatment of treatment.
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Secondary outcome [1]
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post-olanzapine change in glucose and insulin area under curve during oral glucose tolerance test;
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Assessment method [1]
266099
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Timepoint [1]
266099
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testing by glucose tolerance test, by hyperinsulinemic euglycemic clamp) prior to 8 day treatment of olanzapine +/- one of exenatide, metformin or sitagliptin. Tests repeat again on 2 occasions after 8 days treatment.
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Secondary outcome [2]
266101
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change in insulin resistance post-olanzapine;
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Assessment method [2]
266101
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Timepoint [2]
266101
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testing by glucose tolerance test, by hyperinsulinemic euglycemic clamp) prior to 8 day treatment of olanzapine +/- one of exenatide, metformin or sitagliptin. Tests repeat again on 2 occasions after 8 days treatment.
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Secondary outcome [3]
266102
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effect of rescue drugs (exentatide or metformin or sitagliptin) on olanzapine induced changes in GLP-1, glucagon, glucose and insulin resistance.
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Assessment method [3]
266102
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Timepoint [3]
266102
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testing by glucose tolerance test, by hyperinsulinemic euglycemic clamp) prior to 8 day treatment of olanzapine +/- one of exenatide, metformin or sitagliptin. Tests repeat again on 2 occasions after 8 days treatment.
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Eligibility
Key inclusion criteria
BMI 20-25
healthy male volunteers
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
family or personal history of diabetes, schizophrenia.
current regular medications.
smoker
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocating a random number to each subject at enrolment that corresponds to one of the four study groups. Numbers will be concealed in envelopes picked from a box at enrolment by principal investigator.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number out of a list of number 1-20
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/07/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
2999
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New Zealand
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State/province [1]
2999
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Funding & Sponsors
Funding source category [1]
257933
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Government body
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Name [1]
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Health Research Council
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Address [1]
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Level 3, 110 Stanley Street, Auckland, 1010, New Zealand
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Country [1]
257933
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New Zealand
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Primary sponsor type
University
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Name
University of Auckland
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Address
Private Bag 92019, Auckland 1142, New Zealand
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Country
New Zealand
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Secondary sponsor category [1]
257124
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Individual
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Name [1]
257124
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Dr Rinki Murphy
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Address [1]
257124
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Private Bag 92019, Auckland 1142, New Zealand
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Country [1]
257124
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New Zealand
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
259945
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Northern X Ethics Committee
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Ethics committee address [1]
259945
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Private Bag 92-522, Wellesley St
Auckland
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Ethics committee country [1]
259945
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New Zealand
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Date submitted for ethics approval [1]
259945
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01/12/2010
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Approval date [1]
259945
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Ethics approval number [1]
259945
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Summary
Brief summary
Antipsychotic drugs are the second most prescribed medications in New Zealand for the treatment of schizophrenia and other forms of psychosis (Pharmac annual review). Over 40,000 people are prescribed one of the four Pharmac funded second generation antipsychotic drugs (SGAs) clozapine, risperidone, quetiapine or olanzapine, at a cost of $61.6 million NZD annually (Pharmac 2009 annual review). However, the most effective antipsychotic drugs, clozapine and olanzapine, greatly increase the risk of weight gain and type 2 diabetes, and so further increase morbidity, mortality and health care costs. It was previously thought the weight gain was the cause of the type 2 diabetes in these patients but we have recently shown in animal models that these drugs directly impair glucose metabolism. This occurred via suppression of Glucagon-Like-Peptide-1(GLP-1) levels and these defects could be overcome by restoration of GLP-1 signalling. Given the large number of patients on SGA medications it is clearly very important to properly understand how these drugs affect glucose metabolism and what the most appropriate therapies for this are.
We aim to determine whether regulation of the GLP-1/glucagon axis is responsible for the effects SGAs have on glucose metabolism we propose a clinical trial in healthy subjects to test the effect of acute exposure (single dose or 8-day) of olanzapine on glucose tolerance, insulin resistance and hepatic glucose output. We will determine whether this is associated with changes in glucagon and GLP-1 levels (based on the hypothesis developed from our animal data). We will go on to determine whether drug induced impairments in glucose metabolism can best be overcome by restoration of GLP-1 signalling using currently available drugs.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
31833
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Address
31833
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Country
31833
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Phone
31833
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Fax
31833
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Email
31833
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Contact person for public queries
Name
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Shelley Yip
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Address
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Rm 83, Level 12,
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland
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Country
15080
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New Zealand
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Phone
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+64 21 1017436 or +64 9 3737599 ext 81768
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Shelley Yip
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Address
6008
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Rm 83, Level 12,
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland
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Country
6008
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New Zealand
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Phone
6008
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+64 21 1017436 or +64 9 3737599 ext 81768
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Fax
6008
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Email
6008
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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