Therefore, the primary aim of this study is to detect an association between energy expenditure and weight gain.
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of the proposed study is to detect an association between
energy expenditure and weight gain in insulin-induced weight gain in type 2
diabetes mellitus.
Secondary outcome
Furthermore, it is hypothesised that patients who suffer most from
insulin-induced weight gain will have:
1) higher caloric intake
2) higher inflammatory markers
3) lower fat hormones
4) body composition: more (trunk) fat
Background summary
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.
Study objective
Therefore, the primary aim of this study is to detect an association between
energy expenditure and weight gain.
Study design
Prospective, multi-centre design.
Study burden and risks
All the measurements (except for venapuncture) proposed in this protocol are
non-invasive.
postbus 9101
6500 HB Nijmegen
Nederland
postbus 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
• Patients with type 2 diabetes mellitus who will start with insulin therapy
• Age 18-85 years
• Baseline HbA1c < 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), unless 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24179.091.08 |