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van CCT (UK)

van CCT (UK)

Prevention of weight gain when starting insulin therapy in patients with type 2 diabetes.

- candidate number9216
- NTR NumberNTR2798
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-mrt-2011
- Secondary IDs 
- Public TitlePrevention of weight gain when starting insulin therapy in patients with type 2 diabetes.
- Scientific TitlePrevention of insulin induced weight gain in type 2 diabetes: Cognitive behavioural therapy versus Liraglutide.
- hypothesisIn the first 6 months Liraglutide affects weight more than CBT, but CBT provides weight maintenance after 12 months.
- Healt Condition(s) or Problem(s) studiedOverweight, Diabetes Mellitus Type 2 (DM type II), Obesity, Cognitive behavior therapy, Life style, Insuline, Adults, Liraglutide
- Inclusion criteria1. Type 2 diabetes and requiring insulin therapy (novorapid, novomix, levemir);
2. On maximal oral glucose lowering drugs;
3. BMI > 25 kg/m˛;
4. GFR (renal function) > 60 µ mol/l;
5. Age 18-75;
6. Ability to speak Dutch or English.
- Exclusion criteria1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2011
- planned closingdate15-mrt-2013
- Target number of participants118
- InterventionsThe 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.
- Primary outcomePrimary 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 outcomeWe 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.
- TimepointsBaseline, 3 months, 6 months and 12 months.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryMost 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.
- Main changes (audit trail)
- RECORD8-mrt-2011 - 18-mrt-2011

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