Dysglycaemia, schizophrenia, paranoid psycosis, schizotypal disorder MedDRA version: 18.1 Level: LLT Classification code 10036481 Term: Pre-diabetes System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Victoza
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: LIRAGLUTIDE
CAS Number: 204656-20-2
Concentration unit: mg milligram(s)
Concentration type: range
Sponsors
Prof., dr. med. Anders Fink-Jensen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Informed oral and written consent - Diagnosed with schizophrenia, paranoid psychosis or schizotypal disorder according to the criteria of ICD10 (International Classification of Diseases, World Health Organization) or the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, the American Psychiatric Association) - and on stable antipsychotic treatment with either clozapine or olanzapine for at least 6 months (without dose change for at least 30 days) - Stable co-medications for at least 30 days. - Age =18 years and =65 years - Stable weight (defined as less than 5% change in weight over the last 3 month before inclusion) - BMI =27 kg/m2 - Dysglycaemia: 1) HbA1c: 43 mmol/mol = HbA1c = 47 mmol/mol, or 2) Impaired fasting glucose (IFG): Fasting plasma glucose (FPG): 6.1 mmol/l = FPG = 6.9 mmol/l and HbA1c 7.8 mmol/l with a FPG =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: - Compulsory treatment - Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures - Subjects treated with corticosteroids or other hormone therapy (except estrogens) - Any active substance abuse or dependence for the past 6 months (except for nicotine) - Impaired hepatic function (liver transaminases >2 times upper normal limit) - Impaired renal function (se-creatinine >150 µM and/or macroalbuminuria) - Impaired pancreatic function (acute or chronic pancreatitis and/or amylase >2 times upper normal limit) - Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months - Uncontrolled hypertension (systolic blood pressure >180 mmHg, diastolic blood pressure >100 mmHg) - Any condition that the investigator feels would interfere with trial participation - Receiving any investigational drug within the last 3 months - Use of weight-lowering pharmacotherapy within the preceding 3 month - Type 1 or 2 diabetes HbA1c = 48 mmol/mol or on treatment with antidiabetic medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effects of the GLP-1 receptor agonist Liraglutide 6.0 mg/mL, 3.0 mL pre-filled pen-injector (Victoza®) vs. Liraglutide placebo, 3.0 mL pre-filled pen-injector in psychiatric patient in treatment with clozapine or olanzapine.;Secondary Objective: Secondary objectives include changes of dysglycaemia (impaired fasting glucose (IFG), impaired glucose tolerance (IGT), combined IFG/IGT or diabetes), changes in body weight, waist circumference, blood pressure, secretion of incretin hormones, insulin sensitivity and beta cell function, evaluated by homeostatic model assessment (HOMA), DEXA scanning (body composition), lipid profile, liver function, dietary, exercise records and measures of psychopathology, alchohol use and quality of life. Identify differences in risk factors for diabetes between healthy controls and the participants. Also proteomic fingerprinting will be preformed. Furtermore, patients who have been included in the trial, will be approached 52 weeks after end of participation, in order to evaluate whether or not there is a long-term effect of the intervention in regrads to weight and metabolic disturbances. ;Primary end point(s): The primary endpoint is the change in glucose tolerance from baseline (measured by area under the curve (AUC) for the plasma glucose (PG) excursion following a 4-hour 75 g oral glucose tolerance test (OGTT)) to follow up at week 16 or to last observation if study participation is stopped earlier.;Timepoint(s) of evaluation of this end point: 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end points include changes of dysglycaemia (impaired fasting glucose (IFG), impaired glucose tolerance (IGT), combined IFG/IGT or diabetes), changes in body weight, waist circumference, blood pressure, secretion of incretin hormones, insulin sensitivity and beta cell function, evaluated by homeostatic model assessment (HOMA), DEXA scanning (body composition), lipid profile, liver function, dietary, exercise records and measures of psychopathology, alchohol use and quality of life. Identify differences in risk factors for diabetes between healthy controls and the participants. Also proteomic fingerprinting will be preformed. Furthermore, patients who have been included in the trial, will be approached 52 weeks after end of participation, in order to evaluate whether or not there is a long-term effect of the intervention in regards to weight and metabolic disturbances. ;Timepoint(s) of evaluation of this end point: 16 weeks and 1 year | — |
Countries
Denmark
Contacts
Public ContactPsykiatrisk Afdeling O
Psykiatrisk Center København
Outcome results
None listed