Type 2 Diabetes Mellitus Clinical Trial
Official title:
Determinants of Insulin-induced Weight Gain in Type 2 Diabetes Mellitus
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.
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
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