Type 2 Diabetes Mellitus, Weight Gain
Conditions
Keywords
insulin
Brief summary
The purpose of this study is to find determinants of insulin-induced weight gain in type 2 diabetes mellitus Primary objective: To find an association between weight gain after start of insulin therapy and physical activity levels.
Detailed description
Insulin therapy is frequently needed to achieve adequate glycaemic control in type 2 diabetes mellitus (T2DM), but often at the expense of weight gain. Insulin-induced weight gain is obviously undesirable in an already overweight population and may negatively affect blood pressure, lipid levels, inflammatory and fibrinolytic parameters, adipocytokines and also deter further optimization of insulin therapy. It is unknown what determinants predict insulin-induced weight gain in type 2 diabetes mellitus. The aim of this study therefore, is to assess determinants of insulin-induced weight gain in type 2 diabetes mellitus. In a retrospective and cross-sectional study (Jansen HJ et al., submitted) two extreme subgroups were identified (subjects with a weight gain above 80th percentile) and subgroup non-weight gainers (subjects with a weight gain below the 20th percentile). It was found that the gainers had less energy expenditure after initiation of insulin therapy than non-weight gainers. Therefore, the primary aim of this study is to detect an association between energy expenditure and weight gain
Interventions
DEVICESensewear Bodymedia armband
To assess physical activity levels patients will wear Sensewear bodymedia armband
Sponsors
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* patients with type 2 diabetes mellitus * age 18-85 years * Hba1c at baseline \< 12.0% * written informed consent
Exclusion criteria
* Clinical evidence of psychiatric, renal, cardiovascular or liver or other diseases which may influence study results regarding glucose and weight * Patients with hormonal disorders which may influence weight (i.e. thyroid diseases), even if properly treated with stable hormonal levels * Excessive alcohol consumption (\>20 g/day), and drug abuse * Use of thiazolidinedione derivatives (TZDs) * Pregnancy or intention to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To detect an association between insulin-induced weight gain and physical activity levels | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| To assess the relationship between insulin-induced weight gain and cardiovascular risk profile | 1 year |
Countries
Netherlands
Contacts
Primary ContactHenry Jansen, MD
Outcome results
None listed