Onderzoek naar de effecten van het medicijn liraglutide bij patiënten met een type suikerziekte (diabetes) die veroorzaakt is door het gebruik van antipsychotische medicijnen.
- Conditions
- anti-psychotic-drug diabetes mellitus diabetes mellitus veroorzaakt door antipsychotica
- Registration Number
- NL-OMON24018
- Lead Sponsor
- MC Utrecht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
•Informed consent obtained before any trial related activities
•Males or females aged 18 years or older
Exclusion Criteria
•Any type of diabetes present before the use of anti-psychotic drugs
•Use of glucose-lowering medication other than metformin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary end point of this study is the change in HbA1c from baseline to ‘end of trial’
- Secondary Outcome Measures
Name Time Method Efficacy<br /><br>oChange in fasting glucose <br /><br>oChange in body weight and BMI<br /> <br>oChange in waist and hip circumferences and waist hip ratio<br /> <br>oChange in blood pressure<br /><br>oChange in lipid levels<br /><br>oChange in abdominal fat content ( abdominal CT-scan)<br /><br /><br><br>Safety/ Feasibility<br /><br>oCompliance with use of drug liraglutide (number of injection vials used)<br /><br>o(Serious) Adverse events during liraglutide use<br /><br /><br> <br>Change in psychiatric symptoms<br /><br>oCAPE-score<br /><br>oCGI- score<br /><br>oPANS-score<br /><br /><br><br>Patient-reported outcomes<br /><br>oPAID (problem areas in diabetes)<br /><br>oSF-12<br /><br>oDTSQ<br /><br>oEQ5D<br /><br>