Prevention of weight gain when starting insulin therapy in patients with type 2 diabetes.
- Conditions
- type 2 diabetes, insulin therapy, adults, overweight, obesity, weight, glyceamic control, blood glucose, lifestyle, diabetes self management, cognitive behavioral therapy, liraglutide, GLP-1type 2 diabetes, insuline therapie, volwassenen, overgewicht, obesitas, gewicht, glycemische controle, bloedglucose, bloedsuiker, leefstijl, diabetes zelfzorg, cognitieve gedragstherapie, liraglutide, GLP-1
- Registration Number
- NL-OMON20833
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 118
Inclusion Criteria
1. Type 2 diabetes and requiring insulin therapy (novorapid, novomix, levemir);
2. On maximal oral glucose lowering drugs;
Exclusion Criteria
1. Eating disorder or major depression;
2. Alcohol abuse;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome measure is weight change (kg). Mean weight change from baseline to month 6 in the liraglutide arm and CBT arm will be compared. In addition, weight change will be examined at month 12.
- Secondary Outcome Measures
Name Time Method We will examine the insulin consumption and the cost-effectiveness of both treatments. Furthermore, laboratory variables are measured to determine parameters of participants’ health during the study. In addition, diabetes specific psychological parameters are assessed to examine if CBT positively affects psychological well being.