The primary objective of the proposed study is to compare intracellular lipid levels in liver with 1H-magnetic resonance spectroscopy between weight gainers and non-weight gainers after longstanding insulin treatment for type 2 diabetes mellitus.We…
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
see objective of the study
Secondary outcome
see objective of the study
Background summary
Insulin therapy is frequently needed to achieve adequate glycaemic control in
type 2 diabetes mellitus, but often at the expense of weight gain. However,
this weight gain shows large inter-individual differences. It is not exactly
known what kind of mechanisms play a role in these inter-individual
differences. Potential consequences for insulin-induced weight gain may be
change in body-composition (i.e. fat distribution), physical activity, diet and
inflammatory activity. With respect to change in fat distribution, insulin
inhibitis lipolysis and stimulates lipogenesis in adipose tissue and lowers
serum free fatty acids, which might reduce liver fat content. It also
stimulates fatty acids and VLDL synthesis in the liver. It is unclear whether
fat content in the liver is a cause or rather a consequence of
hyperinsulinemia. Juurinen et al. (Am J Physiol Endocrinol Metab, 2007)
examined the role of insulin therapy on liver fat content and hepatic insulin
sensitivity in obese patients with poorly controlled type 2 diabetes. After 7
months of insulin therapy there appeared to be an improvement of hepatic
insulin sensitivity and slightly but significantly reduction of liver fat.
It is not known whether liver fat content changes in patients with type 2
diabetes comparing weight gainers and non-weight gainers after longstanding
insulin therapy. Furthermore, it is not known whether gainers differ in their
fat composition, physical activity and dietary habits compared to non-gainers.
These questions will be tested in this study.
Study objective
The primary objective of the proposed study is to compare intracellular lipid
levels in liver with 1H-magnetic resonance spectroscopy between weight gainers
and non-weight gainers after longstanding insulin treatment for type 2 diabetes
mellitus.
We hypothesised that weight gainers will have higher intracellular lipid levels
than the non-weight gainers.
The secondary objectives of the proposed study will be to compare
body-composition, physical activity, diet and inflammotory markers between
weight gainers and non-weight gainers after longstanding insulin treatment for
type 2 diabetes mellitus.
It is hypothesised that weight gainers will have:
1) more trunk fat
2) lower physical activity
3) higher caloric intake
4) higher inflammatory markers
5) lower fat hormones
Study design
This will be a cross-sectional study recruiting patients who were formerly
studied for weight gain after starting with insulin therapy (Jansen et al.,
article submitted).
Study burden and risks
There are no extra risks regarding the investigation, except for DEXA-scan.
Patients receive by DEXA 12 microSv.
postbus 9101
6500 HB Nijmegen
Nederland
postbus 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
· Type 2 diabetes mellitus
· Premixed insulin
· Age 20-85 years
· HbA1c < 8.5%
· Increase in body weight defined as a weight increase > 6 kg in any given period of 12 months (> 0.5 kg/months over 12 months) over a time period of 12-36 months after start of insulin therapy
· Stable body weight
· Current insulin dose >0.4 IU/kg - < 1.2 IU/kg
· Written informed consent
Exclusion criteria
· Clinical evidence of cardiovascular or liver or other disease
· Treatment with drugs that may alter glucose tolerance, abnormal serum creatinine, macroalbuminuria, proliferative retinopathy, excessive alcohol consumption (>20 g/day), and drug abuse
· Use of thiazolidinedione derivatives (TZDs)
· Patients with pacemakers, ICD*s, implants of metal (prosthesis, (cochlear) ear implants) and patients who experience claustrophobia
· 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 | NL19246.091.07 |