Does a GLP-1 receptor agonist change glucose tolerance in antipsychotic-treated patients?

Prof., dr. med. Anders Fink-Jensen0 个研究点目标入组 100 人开始时间: 2013年3月21日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•- 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 < 48 mmol/mol, or
•3) Impaired glucose tolerance (IGT): two-hour plasma glucose after 75-g oral glucose tolerance test >7.8 mmol/l with a FPG < 7.0 mmol/l and HbA1c < 48 mmol/mol
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•- 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

发起方

Prof., dr. med. Anders Fink-Jensen