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

Prevention of insulin induced weight gain in type 2 diabetes: Cognitive behavioural therapy versus Liraglutide.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20833
Enrollment
118
Registered
2011-03-08
Start date
2011-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Sponsors

Erasmus Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactHanneke Buijks

Postbus 2040

h.buijks@erasmusmc.nl+31 (0)10 7031942

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)