No registrations found.
ID
Source
Brief title
Health condition
anti-psychotic-drug diabetes mellitus
diabetes mellitus veroorzaakt door antipsychotica
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary end point of this study is the change in HbA1c from baseline to ‘end of trial’
Secondary outcome
Efficacy
o Change in fasting glucose
o Change in body weight and BMI
o Change in waist and hip circumferences and waist hip ratio
o Change in blood pressure
o Change in lipid levels
o Change in abdominal fat content ( abdominal CT-scan)
Safety/ Feasibility
o Compliance with use of drug liraglutide (number of injection vials used)
o (Serious) Adverse events during liraglutide use
Change in psychiatric symptoms
o CAPE-score
o CGI- score
o PANS-score
Patient-reported outcomes
o PAID (problem areas in diabetes)
o SF-12
o DTSQ
o EQ5D
Background summary
N/A
Study objective
Liraglutide is an effective and safe treatment modality in metformin-treated patients suffering from schizophrenia with anti-psychotic drugs-related diabetes mellitus.
Study design
0, 6, 12, 24 weken
Intervention
• To explore the efficacy of liraglutide in terms of glycaemic control assessed by HbA1c.
b. Secondary Objectives
• To explore the effect of liraglutide on cardiovascular risk factors, body weight and intra-abdominal fat content using CT-scans in obese patients with antipsychotics-associated diabetes mellitus
• To explore feasibility of liraglutide in the treatment of antipsychotic drugs- associated diabetes and obesity in patients suffering from severe mental illness in terms of compliance with the treatment regimen
• To explore possible change in psychiatric symptoms during treatment with liraglutide in severe mental illness using questionnaires.
Department of Internal Medicine,
P.O. Box 85500
H.W. Valk, de
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)30 2508323
H.W.devalk@umcutrecht.nl
Department of Internal Medicine,
P.O. Box 85500
H.W. Valk, de
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)30 2508323
H.W.devalk@umcutrecht.nl
Inclusion criteria
• Informed consent obtained before any trial related activities
• Males or females aged 18 years or older
• Diabetes mellitus developed while on anti-psychotic drugs for at least six months
• Use of metformin for the treatment of diabetes
• HbA1c >7.0% - ≤ 10.0 mmol/l (53 – 86 mmol/mol)
• BMI 30 – 45 kg/m2
• Regarded capable to understand and follow the protocol
Exclusion criteria
• Any type of diabetes present before the use of anti-psychotic drugs
• Use of glucose-lowering medication other than metformin
• No cardiovascular event in the last 6 months
• Reduced cardiac function (LVEF < 30%)
• No evidence of active retinopathy
• No controlled or uncontrolled hypertension (systolic pressure > 180 mm Hg and/or diastolic pressure > 100 mm Hg
• Renal failure (MDRD < 30 ml/min)
• Liver function abnormalities (ALT and/or AST > 3 times the upper limit of normal)
• History of chronic pancreatitis or previous acute pancreatitis
• Known or suspected hypersensitivity to trial product(s) or related product(s)
• Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
• Participation in another trial or receipt of any investigational medicinal product within 90 days prior to screening
• Subjects who are considered incapable for inclusion by their physicians
• Subjects who are considered inadequate for liraglutide administration themselves or lack network of support
• Subjects who are actively suicidal
• Recurrent use of corticosteroids
• Personal or family history of medullary thyroid carcinoma and patients with multiple endocrine neoplasia type 2 (MEN2)
• Known or suspected abuse of alcohol or narcotics
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4111 |
| NTR-old | NTR4352 |
| Other | HW de Valk : U1111-1144-0576 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |