NCT00781495

Determinants of Insulin-induced Weight Gain in Type 2 Diabetes Mellitus

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Conditions

• Type 2 Diabetes Mellitus
• Weight Gain

Interventions

Type	Name	Description
DEVICE	Sensewear Bodymedia armband	To assess physical activity levels patients will wear Sensewear bodymedia armband

Timeline

• Start date: 2008-12-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2008-10-29
• Last updated: 2011-07-12

Locations

3 sites across 1 country: Netherlands