No registrations found.
ID
Source
Health condition
type 2 diabetes, insulin therapy, adults, overweight, obesity, weight, glyceamic control, blood glucose, lifestyle, diabetes self management, cognitive behavioral therapy, liraglutide, GLP-1
type 2 diabetes, insuline therapie, volwassenen, overgewicht, obesitas, gewicht, glycemische controle, bloedglucose, bloedsuiker, leefstijl, diabetes zelfzorg, cognitieve gedragstherapie, liraglutide, GLP-1
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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.
Background summary
Most people with type 2 diabetes on maximum oral glucose lowering drugs
need insulin therapy to improve glycaemic control. However, insulin
induced weight gain is undesirable since the majority of this population
already is overweight. Weight gain is associated with insulin resistance
and increased risk of cardiovascular complications. Therefore, insulin
therapy associated weight gain should be prevented. In our study we
compare the preventive effects on insulin induced weight gain of two
different therapies that are associated with weight loss in patients
with type 2 diabetes: Liraglutide and Cognitive Behavioral Therapy.
Study objective
In the first 6 months Liraglutide affects weight more than CBT, but CBT provides weight maintenance after 12 months.
Study design
Baseline, 3 months, 6 months and 12 months.
Intervention
The interventions are 26 weeks liraglutide or 26 weeks cognitive behavioral therapy added to insulin therapy and usual care.
Liraglutide is a long-acting glucagon-like peptide-1 (GLP-1) analog that provides glycemic control and avoids hypoglycemia without the additional weight gain that characterizes many other glucose lowering drugs. The dose of liraglutide is 0.6 mg daily in the first week, 1.2 mg daily in the second week and 1,8 mg daily from the third week by subcutaneous injection.
The cognitive behavioral treatment consists of 8 individual meetings (45 minutes each) and 4 group meetings (90 minutes each) with a psychologist. In these meetings dysfunctional cognitions that lead to unhealthy behavior are gradually uncovered, challenged and changed into more functional cognitions that are more likely to lead to healthy behavior.
Hanneke Buijks
Erasmus MC
Afd. Medische Psychologie & Psychotherapie
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7031942
h.buijks@erasmusmc.nl
Hanneke Buijks
Erasmus MC
Afd. Medische Psychologie & Psychotherapie
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7031942
h.buijks@erasmusmc.nl
Inclusion criteria
1. Type 2 diabetes and requiring insulin therapy (novorapid, novomix, levemir);
2. On maximal oral glucose lowering drugs;
3. BMI > 25 kg/m²;
4. GFR (renal function) > 60 µ mol/l;
5. Age 18-75;
6. Ability to speak Dutch or English.
Exclusion criteria
1. Eating disorder or major depression;
2. Alcohol abuse;
3. History of pancreatitis & thyroid disorders;
4. Inflammatory Bowel Syndrome;
5. Pregnancy or lactating;
6. Use of insulin;
7. Known allergy to Liraglutide;
8. Use of Liraglutide within 3 months before entering study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL2670 |
| NTR-old | NTR2798 |
| Other | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |